ARROW W-04018-143D Positive Placement Spring Wire Instruction Manual
- June 21, 2024
- Arrow
Table of Contents
Positive Placement Spring-Wire Guide
Rx only
W-04018-143D Positive Placement Spring Wire
Intended Purpose:
To facilitate the placement of devices for diagnostic and interventional
procedures.
Patient Target Group:
Intended to be used in patients with anatomy suitable for use with the device.
Contraindications:
None known.
Clinical Benefits to be Expected:
The ability to guide and control the advancing movement of the catheter body
through the vessel, to gain access to the vascular system through a single
puncture site access.
Performance Characteristics:
To facilitate Seldinger insertion and provide rigidity to guide the catheter
into the vasculature.
Contains Hazardous Substance:
Guidewires manufactured using Stainless Steel can contain > 0.1% weight by
weight of Cobalt (CAS # 7440-48-4) which is considered a category 1B CMR
(Carcinogenic, mutagenic or toxic to reproduction) substance. The amount of
Cobalt in the Arrow guidewires has been evaluated and considering the intended
purpose and toxicological profile of the device there is no biological safety
risk to patients when using the device as instructed within this IFU.
General Warnings and Precautions
Warnings:
-
Sterile, Single use: Do not reuse, reprocess or resterilize.
Reuse of 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.
-
Do not apply excessive force in removing guidewire. If withdrawal cannot be easily accomplished, a radiograph should be obtained and further consultation requested.
-
Clinicians must be aware of complications/undesirable side effects associated with spring-wire guide use including, but not limited to:
- knotting/kinking
- separation of the coil and core wires
- vessel perforation
- malposition
- guidewire retention/ intravascular loss
- guidewire entrapment
- arterial puncture
- posterior wall puncture
- bleeding
- mediastinal hematoma
- pleural effusion
Precautions:
- Do not alter the spring-wire guide during insertion, use, or removal.
- Procedure must be performed by trained personnel well versed in anatomical landmarks, safe technique and potential complications.
- Use standard precautions and follow institutional policies for all procedures including safe disposal of devices.
- If the package is damaged or unintentionally opened before use do not use the device. Dispose of the device.
- Storage conditions for these devices require that they are kept dry and out of direct sunlight.
Catheter Introduction
-
Attach spring-wire tube assembly to hub of needle.
-
Remove protective shield from catheter (if applicable). Trial advance and retract spring-wire guide through needle using actuating lever to ensure proper function.
**** Precaution: Prior to insertion actuating lever must be retracted proximally as far as possible or blood flashback may be inhibited. -
Follow institutional policies and procedures for patient preparation and vessel access.
-
Puncture vessel using a continuous, controlled, slow, forward motion. Avoid transfixing both vessel walls.
**** Precaution: If both vessel walls are punctured, subsequent advancement of spring-wire guide could result in inadvertent subvascular placement.
Blood flashback in hub of introducer needle indicates successful entry into vessel. -
Stabilize position of introducer needle and carefully advance spring-wire guide as far as required into vessel using actuating lever (refer to Figure 1).
Precaution: Do not advance guidewire unless there is free blood flashback.
When reference mark of clear feed
tube coincides with edge of internal cylinder of actuating lever, the tip of
spring-wire guide is located at the needle tip.
Precaution: Do not use excessive force when introducing spring-wire guide as this can lead to vessel perforation and bleeding.
**** Warning: Do not retract spring-wire guide against edge of needle while in vessel to reduce the risk of spring-wire guide damage.
If resistance is encountered during spring-wire guide advancement, withdraw entire unit and attempt new puncture. -
Advance entire placement device a maximum of 1 to 2 mm further into vessel.
-
Firmly hold introducer needle hub in position and advance catheter forward with a slight rotating motion over spring-wire guide into vessel.
-
Hold catheter in place and remove needle and spring-wire guide assembly. Pulsatile blood flow indicates positive arterial placement.
Precaution: Do not reinsert needle into catheter to reduce risk of catheter damage.
Warning: Do not apply excessive force in removing spring-wire guide to reduce the risk of breakage. -
Verify that entire spring-wire guide is intact upon removal.
-
Complete procedure per institutional policies and procedures.
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
For a patient/user/third party in the European Union and in countries with
identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if,
during the use of this device or as a result of its use, a serious incident
has occurred, please report it to the manufacturer and/or its authorized
representative and to your national authority. The contacts of national
competent authorities (Vigilance Contact Points) and further information can
be found on the following European Commission website:
https://ec.europa.eu/growth/sectors/medical-devices/contacts_en
Symbol Glossary: Symbols are in compliance with ISO 15223-1.
Some symbols may not apply to this product. Refer to product labeling for
symbols that apply specifically to this product.
Arrow, the Arrow logo, Teleflex and the Teleflex logo are trademarks or
registered trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries. © 2023 Teleflex Incorporated. All rights reserved.
“Rx only” is used within this labeling to communicate the following statement
as presented in the FDA CFR :
Caution: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
EU Authorized Representative and Importer:
Teleflex Medical
IDA Business and Technology Park
Dublin Road, Athlone, Co. Westmeath, Ireland
W-04018-143D, Rev. 01 (2023-11)
Arrow International LLC
Subsidiary of Teleflex Incorporated
3015 Carrington Mill Blvd., Morrisville, NC 27560 USA
USA: 1 866 246 6990 | International: +1 919 544 8000