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	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "folded guide".This was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "folded guide".This was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened arterial kit for analysis.No obvious signs of use were observed.The guide wire tubing was not returned for analysis.Visual analysis revealed one kink on the guide wire.Creasing is also visible on the pouch.Analysis of the pouch revealed that the words "do not bend" are visible on the top and bottom of the lidstock.Microscopic examination confirmed the damage and revealed that the distal and proximal welds of the guide wire are full and spherical.The kink on the guide wire measured 123mm 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.The guide wire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "thread tip of catheter over guidewire".The guide wire was advanced through the catheter.Resistance was encountered at the location of the kink; however, the guide wire was able to pass through the catheter.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 ifu provided with the kit informs the user, "do not use if package is damaged".The customer report of a kinked guide wire was confirmed through investigation of the returned sample.One kink was observed on the guide wire body.Subsequent creasing was also observed on the outer pouch.Despite this, the guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.The returned product lidstock clearly states , "do not bend".Based on the customer description and the sample received , storage and shipping likely 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 "folded guide".This was found prior to use.There was no patient involvement.

• 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: 23632328
• Report Number: 3006425876-2025-01116
• Device Sequence Number: 21452123
• Product Code: DQY
• UDI-Device Identifier: 10801902129915
• UDI-Public: (01)10801902129915(11)240925(17)290831(10)71F24J0714(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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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
• Device Catalogue Number: SAC-00822-PBX
• Device Lot Number: 71F24J0714
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/26/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/02/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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.; NOT REPORTED.
• Patient Sex: Unknown