MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 22GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-00822-PBX
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that upon opening the arterial kit, evidence of a bent guidewire was observed.The patient had no harm or injury.
Event or Problem Description
It was reported that upon opening the arterial kit, evidence of a bent guidewire was observed.The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The complaint of a kinked guidewire was able to be confirmed by the photo.The guidewire was within the kit packaging and the appearance of the damage is consistent with folding of the kit resulting in damage to the guidewire.The customer also returned one, opened arterial kit for analysis.The returned sample matches the sample pictured in the customer photo.Only the guide wire was included.The guide wire tubing, the needle, and the catheter were not returned with the sample.Visual analysis confirmed that the guide wire was kinked.No obvious damage was observed on the returned pouch.The kink on the guide wire measured 160mm from the weld.The guide wire length measured 350mm, which is within the specification limits of 345mm-355mm per the guidewire product drawing.The guide wire outer diameter measured 0.51mm, which is within the specification limits of 0.508mm-0.533mm per the guidewire product drawing.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The words "do not bend" are visible on the top of bottom.The ifu provided with the kit informs the user, "do not use if package is damaged".The report that the guide wire kinked prior to use was confirmed through analysis of the returned sample.Visual analysis revealed a single kink around the middle of the guide wire.Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, storage/shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 22GA X 8CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21575290
• Report Number: 3006425876-2025-00301
• Device Sequence Number: 20919498
• Product Code: DQY
• UDI-Device Identifier: 10801902129915
• UDI-Public: (01)10801902129915(11)240812(17)290731(10)71F24H0046(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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 Catalogue Number: SAC-00822-PBX
• Device Lot Number: 71F24H0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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
• Patient Sex: Female