MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "once we have access to the vessel, we thread the guidewire through the introducer needle.Then, we remove the introducer needle and run the catheter over the guidewire within the femoral artery.Unfortunately, we have not been able to advance the femoral arterial catheter over the guidewire past 0.5-1cm.Some femoral arterial catheters narrow significantly or kink at around 0.5 - 1cm, so that we cannot advance the catheter over the guidewire into the femoral artery." there was no medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2025-00525,.9680794-2025-00523, and 9680794-2025-00521.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "once we have access to the vessel, we thread the guidewire through the introducer needle.Then, we remove the introducer needle and run the catheter over the guidewire within the femoral artery.Unfortunately, we have not been able to advance the femoral arterial catheter over the guidewire past 0.5-1cm.Some femoral arterial catheters narrow significantly or kink at around 0.5 - 1cm, so that we cannot advance the catheter over the guidewire into the femoral artery." there was no medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2025-00525, 9680794-2025-00524, 9680794-2025-00523, and 9680794-2025-00521.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of arterial catheter blocked could not be confirmed by the photo as the image provided was only an illustration of where the defect occurred, and it did not reveal any defect on the actual sample.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "grasping near skin, advance catheter into vessel.Hold catheter in place and remove guidewire and/or assembly, where applicable.Precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22309776
• Report Number: 9680794-2025-00524
• Device Sequence Number: 8705602
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)250416(17)270831(10)33F25C0742(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: ASK-04018-UPM
• Device Lot Number: 33F25C0742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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