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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the intensivist facing the guide wire and catheter both inside the packing comes damaged all the time." this was found prior to use during inspection.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the intensivist facing the guide wire and catheter both inside the packing comes damaged all the time." this was found prior to use during inspection.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Additional Manufacturer Narrative
(b)(4) the customer returned one unopened sac-00820 arterial kit for analysis.No definite signs of use were observed.Visual analysis of the guidewire revealed the guidewire was kinked in multiple places throughout the body.Visual analysis also revealed the returned packaging contained one major fold and the catheter and protective tubing each had a kink all aligning with the location of the kinks in the guidewire.Microscopic examination confirmed the kinks and revealed that both welds were present and spherical.Additionally, the product lidstock states "do not bend".The kinks in the guidewire were located 65mm and 88mm from the proximal end.The overall length of the guidewire measured 349mm, 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.A manual tug test confirmed that the distal and proximal welds were intact.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, "do not use if package is damaged".The lidstock was reviewed and the words "do not bend" are clearly visible on the front of the lidstock.A change 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.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 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 "the intensivist facing the guide wire and catheter both inside the packing comes damaged all the time." this was found prior to use during inspection.

• 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: 22469043
• Report Number: 3006425876-2025-00627
• Device Sequence Number: 7986210
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)240220(17)290131(10)71F24B0506(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F24B0506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 11/25/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/31/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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