MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8IN; WIRE GUIDE CATHETER

Catalog Number	RA-04122
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an equipment failure occurred in the ed during an attempt to place an artery line in the patient's right arm.A flash of blood was visualized, and an attempt was made to thread the catheter the rest of the way.Resistance was encountered when trying to remove the needle from the catheter.The entire device was then removed from the patient's arm, and it was found that the needle was bent.The device was replaced to resolve the issue.
Event or Problem Description
It was reported that an equipment failure occurred in the ed during an attempt to place an artery line in the patient's right arm.A flash of blood was visualized, and an attempt was made to thread the catheter the rest of the way.Resistance was encountered when trying to remove the needle from the catheter.The entire device was then removed from the patient's arm, and it was found that the needle was bent.The device was replaced to resolve the issue.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided four photos for analysis.The photos show an ra-04122 catheterization device with excess biological material and a kinked distal end.The customer also returned one arterial catheterization assembly for analysis.Signs of use in the form of biological material were observed on and within the device.Visual and microscopic revealed the catheter was partially advanced off the needle hub and the guide wire had two kinks towards the distal end.Excess biological material was observed on the guide wire and 10 mm of the guide wire was advanced past the distal tip of the catheter upon return.The catheter was kinked due to the kinks in the guide wire.The distal weld was full and spherical.No signs of adhesive nor other defects or anomalies were observed on the device.During functional testing (see below), excess biological material was observed between the catheter and needle cannula; however, no defects or anomalies were observed on the needle cannula.The major kinks in the guide wire were located 9 mm and 20 mm from the distal tip.The outer diameter of the guide wire measured 0.403 mm, which is within the specification limits of 0.381-0.404 mm per guide wire product drawing.Dimensional analysis of the catheter could not be accurately performed due to the nature of the damage on the returned device.Functional testing was performed based on the instructions for use (ifu).The ifu provided with this kit states , "stabilize position of introducer needle and carefully advance guidewire into vessel using guidewire handle." the guide wire attempted to be retracted to re-advance through the returned cannula; however, the guide wire was stuck within the cannula due to excess biological material.Undue force was used to remove the guide wire/advance the catheter off the cannula resulting in the guide wire to unravel and the catheter to crumple while remaining stuck on the guide wire.Excess biological material was observed between the catheter and needle cannula; however, no defects or anomalies were observed on the needle cannula.Functional testing could not be performed due to the nature of the returned device and excess biological material.The condition of the sample suggests the guide wire was advanced through the catheter and encountered resistance resulting in the guide wire to kink.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "if resistance is encountered while advancing spring-wire guide do not force feed.Warning: do not retract spring-wire guide against edge of needle while in vessel to minimize the risk of spring-wire guide damage." the report of guide wire and catheter resistance with a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed the guide wire was kinked towards the distal end and dried biological material was within the device.Functional analysis revealed biological material between the catheter, cannula, and on the guide wire.The condition of the sample and the customer report suggests the guide wire was advanced through the catheter and encountered resistance while attempting to remove the guidewire resulting in the guide wire to kink.Based on these circumstances, unintentional use error likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
(b)(4).Medwatch received 31-jan-2025.
Event or Problem Description
It was reported that an equipment failure occurred in the ed during an attempt to place an artery line in the patient's right arm.A flash of blood was visualized, and an attempt was made to thread the catheter the rest of the way.Resistance was encountered when trying to remove the needle from the catheter.The entire device was then removed from the patient's arm, and it was found that the needle was bent.The device was replaced to resolve the issue.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8IN
• Common Device Name: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21160049
• Report Number: 9680794-2025-00001
• Device Sequence Number: 20937408
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)200821(17)250731(10)14F20H0077(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: RA-04122
• Device Lot Number: 14F20H0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/16/2025; Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/22/2025; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White