MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 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	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the swg was found to be kinked prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened arterial kit for analysis.No signs of use in the form of biological material were observed; however, it was noted that the 20ga introducer needle was inserted over the distal end of the guide wire.During normal packaging, this 20ga introducer needle is not assembled over the guide wire.Instead, the needle should be by itself within the kit with the protective guard over the cannula.This indicates that the customer handled the device.It was noted that the needle guard nor the protective swg tubing were returned.Visual analysis revealed that guide wire was kinked in two locations.One kink was clearly visible, while the other kink was located inside the catheter body.This resulted in the catheter body to also appear kinked.Crease marks were observed on the pouch which are consistent with folding of the pouch during storage and/or handling.Visual analysis could not be performed on the protective guide wire tubing as it was not returned.The kinks on the guide wire measured 133mm and 192mm from the proximal weld.The guide wire total length measured 350mm, which is within the specification limits of 345mm-355mm per the guide wire product drawing.The guide wire outer diameter measured 0.510mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire 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 the returned 20 ga introducer needle.Major resistance was encountered at the location of the kinks; however, all functional areas were able to pass with little to no difficulty.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 the kit informs the user, "precaution: use of excessive force may damage catheter or guidewire.Do not use if package is damaged".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, folds and creases were observed on the outer 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.
Event or Problem Description
It was reported that: the swg was found to be kinked prior to use.There was no patient involvement.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18876021
• Report Number: 3006425876-2024-00308
• Device Sequence Number: 9135750
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/26/2024
• 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; NOT REPORTED
• Patient Sex: Unknown