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	06/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "patient with indication for arterial catheter placement; during the purging of the device, the white protector is removed and a fractured guide is observed in the body of the catheter." this was found prior to use.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one catheter, guidewire, and protective tubing for evaluation.No obvious signs of use were noted.Visual analysis revealed one kink towards the proximal end and two additional kinks along the central body of the guidewire.No defects or anomalies were observed on the catheter.The lidstock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.Microscopic examination confirmed the damage and confirmed the distal and proximal welds were secure and intact.The guidewire length measured 348mm, which is within the specification limits of 345mm - 355mm per the guidewire product drawing.The guidewire outer diameter measured 0.517 mm, which is within the specification limits of 0.508-0.533 mm per guide wire product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." the guidewire was advanced through a lab inventory 18 ga introducer needle, and the undamaged portions were able to pass with no resistance.Resistance was encountered at the locations of the kinks.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 this kit warns the user, "do not use if package is damaged." the lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.The customer's report of a kinked guidewire was confirmed during the complaint investigation of the returned sample.Multiple kinks were observed along the guidewire body, and the protective tubing was also found to be bent.However, the guidewire met all relevant dimensional and functional specifications.The packaging clearly states, "do not bend." based on the customer description and the samples received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22770508
• Report Number: 3006425876-2025-00733
• Device Sequence Number: 9449827
• Product Code: DQY
• UDI-Device Identifier: 10801902129915
• UDI-Public: (01)10801902129915(11)241128(17)291031(10)71F24L0943(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
• Report Date (Section B): 07/15/2025

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: 71F24L0943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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
• Patient Sex: Unknown