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	Material Frayed (1262); Failure to Advance (2524)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
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." additional information received states "all components removed from patient with wire visibly frayed but not within patient." it was reported there was no overt harm to the patient, potential blood loss from wire failure and pressure applied groin".There was no medical intervention required.The patient's current condition is reported as "deceased" due to unrelated issues.Associated mdr numbers include: 9680794-2025-00525, 9680794-2025-00524, 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 an unraveled guidewire could not be confirmed by the photo as the image provided was only an illustration of where the catheter was blocked, 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, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).At this point, the depth-marking entering hub shows that tip of wire leaves tip of introducer needle and enters vessel.If catheter/needle assembly is used, remove needle and insert guidewire through catheter into artery as described above.If "j" tip guidewire is used, prepare for insertion by sliding straightening tube over "j" to straighten and advance guidewire to required depth.Precaution: do not advance guidewire unless there is free blood flashback." 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.
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 to 1cm, so that we cannot advance the catheter over the guidewire into the femoral artery." additional information received states "all components removed from patient with wire visibly frayed but not within patient." it was reported there was no overt harm to the patient, potential blood loss from wire failure and pressure applied groin".There was no medical intervention required.The patient's current condition is reported as "deceased" due to unrelated issues.Associated mdr numbers include: 9680794-2025-00525, 9680794-2025-00524, 9680794-2025-00523, and 9680794-2025-00521.

• 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: 22328321
• Report Number: 9680794-2025-00523
• Device Sequence Number: 20935423
• 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: Physician
• 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: 06/25/2025
• 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): 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