MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00820
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the hcp found the swg was kinked before use on patient.".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened sac kit for analysis.No evidence of use was observed.Visual inspection of the components revealed one kink in the guide wire body.Several creases on the product packaging and bending of the catheter were also observed.The damage observed is consistent with defects related to storage and shipping.Both welds were present and appeared full and spherical.The packaging additionally clearly states, "do not bend".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 undamaged portions of the guide wire were threaded through the returned 20 ga introducer needle, and little to no resistance was experienced.A device history record review was performed, and no relevant findings were identified.The instructions for use (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 (april 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.One kink was observed on the guide wire body.In addition, several folds and creases were observed on the outside packaging.The guide wire met all relevant dimensional 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: ARROW ARTERIAL CATH SET: 20 GA 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19937817
• Report Number: 3006425876-2024-00766
• Device Sequence Number: 17381676
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)220428(17)270331(10)71F22D1703(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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 Catalogue Number: SAC-00820
• Device Lot Number: 71F22D1703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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