ARROW AK-09001 Teleflex Incorporated Vascular Access User Manual

: June 5, 2024
: Arrow

Table of Contents

ARROW AK-09001 Teleflex Incorporated Vascular Access
Introduction
General Warnings and Precautions
Precautions
A Suggested Procedure: Use a sterile technique
Symbol
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ARROW AK-09001 Teleflex Incorporated Vascular Access

Introduction

Peritoneal lavage is based on the simple concept that the presence of intraperitoneal blood indicated intraperitoneal injury. This procedure can be rapidly and accurately performed in the emergency room as a diagnostic tool in the assessment of seriously injured patients with blunt abdominal trauma. This Arrow® kit utilizes a “J” tipped guidewire for catheter placement obviating the older complication-prone trocar technique. A volume of approximately one liter of normal saline or Ringer’s lactate is instilled into the peritoneal cavity and then recovered and analyzed for blood content. The physician using the Arrow® Peritoneal Lavage Kit is provided with everything needed to diagnose intraperitoneal bleeding with increased safety, reliability, and convenience. A 20 Ga. short bevel introducer needle is the largest sharp object to enter the peritoneum. The very soft “J” tip of the guidewire minimizes the potential for complications.

Indications for Use:
For evaluation of bleeding in the abdominal cavity or ruptured organ.

Contraindications:
Patients with an acute abdomen requiring immediate surgery or penetrating abdominal trauma.

General Warnings and Precautions

Warnings:

Sterile, Single-use: Do not reuse, reprocess or resterilize. Reuse of the device creates a potential risk of serious injury and/or infection which may lead to death. Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality.
Read all package insert warnings, precautions, and instructions prior to use. Failure to do so may result in severe patient injury or death.
Clinicians must be aware of complications associated with peritoneal lavage including, but not limited to injury to organs and/or vessels by needle or catheter, infection, cutaneous bleeding, and/or hematoma.

Precautions

Do not alter the catheter, guidewire, or any other kit/set component during insertion, use, or removal.
The procedure must be performed by trained personnel well versed in anatomical landmarks, safe techniques, and potential complications.
Use standard precautions and follow institutional policies for all procedures including safe disposal of devices.

Kits/Sets may not contain all accessory components detailed in these instructions for use. Become familiar with instructions for individual component(s) before beginning the procedure.

A Suggested Procedure: Use a sterile technique

Place the patient in a supine position making sure that the patient has voided or urinary catheter is in place. Insert nasogastric tube to decompress stomach.
The preferred site for catheter insertion is the midline, midway between the umbilicus and the symphysis pubis. Avoid insertion through or immediately adjacent to a previous abdominal incision.
Remove prep swab sticks and prep shaved skin in the area of the puncture site.
Remove the wrapped tray from the outer package and open it to create a sterile field and expose kit components for use.
Place a fenestrated drape over the puncture site.
Use 18 Ga. T.W. needle to aspirate anesthetic into 5 mL syringe.
Perform skin wheal using a 25 Ga. or 22 Ga. needle.
Make a 3 mm skin incision using a #11 blade scalpel.
Note: Do not proceed until the skin and subcutaneous hemostasis is observed.
Insert catheter/needle assembly through the incision into the peritoneum aiming toward the pelvic hollow.

Note:
18 Ga. T.W. needle (without catheter) can be alternately used to puncture peritoneum and pass wire guide if desired. If desired, the catheter/needle assembly can be connected to I.V. tubing and a bottle/bag of saline or Ringer’s lactate solution.

The penetration into the peritoneum will usually be recognized by a distinct “pop” and confirmed by a free flow of solution. Advance tip of the catheter an additional 2-3mm into the peritoneal cavity. Remove the introducer needle (refer to Figure 1).

Precaution:
If the needle is used instead of the introducer catheter, do not withdraw the guidewire against the needle bevel to avoid possible severing of the guidewire. Precaution: Do not reinsert the needle into the catheter.

Insert the desired end of the guidewire through a 16 Ga. catheter into the peritoneal cavity. If the “J” tip is used, prepare for insertion by sliding a plastic tube over the “J” to straighten it. Advance guidewire into peritoneum to the required depth.

Note: If the wire does not initially advance with ease, the catheter most likely has not been placed properly within the peritoneal cavity (refer to Figure 2).

Remove introducer catheter and thread tip of 8 Fr. catheter over a guidewire (be certain that sufficient wire guide length remains exposed at the hub end of the catheter to maintain a firm grip on wire guide). Grasping near the skin, advance the catheter to the required depth in the peritoneal cavity (refer to Figure 3).

Precaution:
Maintain a firm grip on guidewire at all times.

Hold catheter at the required depth and remove guidewire. Aspirate using a 5 mL syringe.

Precaution:
Potential for guidewire breakage. Although the incidence of guidewire failure is extremely low, physicians should be aware of the potential for breakage if undue force is applied to the wire. The Arrow catheter included in this product has been designed to freely pass over the guidewire; if resistance is encountered when attempting to remove the guidewire after catheter placement, the guidewire may be kinked about the tip of the catheter (refer to Figure 4). In this circumstance, pulling back on the guidewire may result in undue force being applied resulting in guidewire breakage. If resistance is encountered, withdraw the catheter relative to the guidewire about 2-3 cm and attempt to remove the guidewire; if resistance is again encountered, remove the guidewire and catheter simultaneously.

If aspiration is non-diagnostic, connect I.V. tubing to catheter and bottle/bag of saline or Ringer’s lactate (20 mL/kg up to 1000 mL). Run solution into the peritoneal cavity. Gently manipulate patient as required to insure proper intermixing of fluid. The suggested time to allow for intermixing is 10 minutes (refer to Figure 5).

Lower bottle/bag and I.V. tubing to floor level so that lavage fluid can drain freely by gravity due to siphoning effect.

Note:
If no fluid return occurs, reinsert the guidewire and again check for fluid return after wire guide removal. If the fluid return still does not occur, flush the catheter with saline solution. If the fluid return still does not occur, exchange the old catheter with a new one utilizing wire guide (refer to Figure 6).

Analyze fluid for red blood cells or other material as indicated using standard hospital technique. After lavage has been accomplished, remove the catheter and dress the puncture site as required.

For reference literature concerning patient assessment, clinician education, insertion technique, and potential complications associated with this procedure, consult standard textbooks, medical literature, and Arrow International LLC website: www.teleflex.com A pdf copy of this IFU is located at www.teleflex.com/IFU.

Symbol

Symbol Glossary: Symbols are in compliance with ISO 15223-1. Some symbols may not apply to this product. Refer to the product labeling for symbols that apply specifically to this product.

Teleflex, the Teleflex logo, Arrow, and the Arrow logo are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2021 Teleflex Incorporated. All rights reserved.