MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET: 20 GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00520
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " sgw was kinked prior to patient use".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one opened sac kit for evaluation.No signs of use were observed.Visual inspection of the guide wire revealed multiple kinks in the guide wire body.Microscopic examination confirmed the damage.Both welds were present and appeared full and spherical.Creasing and bending was also observed on the guide wire protective tubing and the product packaging.The lidstock clearly states "do not bend".The kinks in the guide wire measured 229mm, 330mm, and 335mm from the proximal end.The guide wire length measured 349mm which is within the specification of 345-355mm per product drawing.The guide wire outer diameter measured 0.521mm which is within the specifications of 0.508-0.533mm per product drawing.Functional inspection of the guide wire was performed per the instructions for use (ifu) provided with the kit which states, "insert desired tip of spring-wire guide through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).Thread tip of indwelling catheter over spring-wire guide." the guide wire was threaded through a lab inventory 20 ga introducer needle and little to no resistance was experienced.A manual tug test confirmed the distal and proximal welds were attached.The manufacturing site was previously consulted regarding the observed failure mode for related complaints.They indicated that the observed kink, in addition to the creasing in the packaging, is consistent with damage caused by shipping and handling.As part of the guide wire manufacturing process, each guidewire is passed through a ring gauge so it is unlikely that this defect would have been present prior to release from the manufacturing site.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user , "precaution: use of excessive force may damage catheter or guidewire.Do not use if package is damaged." an engineering change order (eco) was implemented in april 2017 to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.This product was manufactured (september 2022) after the implementation date of the eco.The lidstock clearly states, "do not bend." the customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.Multiple kinks were observed on the guide wire body.In addition, several folds and creases were observed on the protective tubing and outside packaging.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The lidstock clearly states "do not bend." based on the customer description and the sample received , storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARTERIAL CATH SET: 20 GA X 5CM
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18864745
• Report Number: 3006425876-2024-00214
• Device Sequence Number: 8294875
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: 10801902144062
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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
• Device Catalogue Number: SAC-00520
• Device Lot Number: 71F22H4016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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
• Patient Sex: Unknown