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	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn #: (b)(4).
Event or Problem Description
It was reported that, "it was found that the wire is bent, prior to use on patient." there was no patient involvement.
Event or Problem Description
It was reported that "it was found that the wire is bent, prior to use on patient." there was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened sac arterial kit for analysis.No obvious signs of use were observed.The guide wire was returned assembled inside the catheter body.Visual analysis revealed two kinks on the catheter body.The guide wire was removed from the catheter and identical kinking was visible in the same locations on the guide wire surface.Microscopic examination confirmed the damage and revealed creasing on the guide wire tubing in the same location as the kinks.Further analysis also revealed that the distal and proximal welds were secure and intact.Based on the customer description, the damage observed is consistent with defects related to storage and shipping.The kinks on the guide wire measured 81mm and 113mm from the proximal weld.The guide wire length measured 349 mm, which is within the specification limits of 345-355 mm per guide wire product drawing.The guide wire outer diameter measured 0.510mm, which is within the specification limits of 0.508-0.533 mm per 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.Precaution: allow sufficient guidewire length to remain exposed at hub end of catheter to maintain firm grip on guidewire.Grasping near skin, advance catheter into vessel." the guide wire was advanced through the returned catheter, and the undamaged portions were able to pass with no resistance.Resistance was encountered at the location of the kinking.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 lidstock label was reviewed and the words "do not bend" are clearly visible on the front of the lidstock.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Two kinks were observed on the guide wire body.Despite this, the guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The product lidstock for finished good sac-00820 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.

• 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: 21995474
• Report Number: 3006425876-2025-00458
• Device Sequence Number: 17297844
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)240115(17)281231(10)71F24A0446(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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-00820
• Device Lot Number: 71F24A0446
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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