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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "before a line procedure, as soon as taking out catheter from the box, wire was kinked and replaced it with another product." this was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one unopened sac-01220-pbx arterial kit for analysis.No definite signs of use were observed.Visual analysis of the guidewire revealed one kink.Visual analysis also revealed the returned packaging contained one major fold and a kink in the catheter and protective tubing.This aligned with the kink in the guidewire.Microscopic examination confirmed the kink and revealed that both welds were present and spherical.Additionally, the product lidstock states "do not bend".The kink in the guidewire was located 57mm from the one tip.The overall length of the guidewire measured 349mm, which is within the specification limits of 345mm-355mm per the guidewire product drawing.The guidewire outer diameter measured 0.510mm, which is within the specification limits of 0.508mm-0.533mm per the guidewire product drawing.Functional inspection of the guidewire was performed per the instructions for use (ifu) provided with the kit which states, "thread tip of catheter over guidewire." the returned guidewire was threaded through the returned catheter and introducer needle.The undamaged portions of the guidewire were able to advance with no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "do not use if package is damaged." the customer report of a damaged guidewire was confirmed through investigation of the returned sample.The guidewire was kinked in the middle of the body and the returned packaging each contained one major fold as well.The guidewire met all relevant functional requirements, and a device history record review was performed with no relevant findings.The packaging clearly states "do not bend." based on the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " before a line procedure, as soon as taking out catheter from the box, wire was kinked and replaced it with another product." this was found prior to use.There was no patient involvement.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24415030
• Report Number: 3006425876-2026-00205
• Device Sequence Number: 21484718
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)240213(17)290131(10)71F24B0107(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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-00820
• Device Lot Number: 71F24B0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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: Unknown