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	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "attempted to place right femoral groin arterial line utilizing arrow arterial catheterization 18-gauge kit.Access was obtained under ultrasound guidance but unable to thread catheter over a wire.Upon removal of catheter and wire distal tip of wire was noted to be bunched and there was a kink and wire approximately at midpoint.Patient required second attempt at femoral a-line access.Was able to successfully place second femoral access kit." there was no medical intervention required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire for analysis.Signs of use were observed on the guidewire surface.The needle or catheter involved with this complaint was not returned.Visual analysis revealed that the guidewire contained one kink and overlapped coils towards the distal end.Microscopic examination confirmed the damage and revealed that the distal j-bend was slightly misshapen.It was also noted that the distal and proximal welds were full and spherical.Visual analysis could not be performed on the needle involved with this complaint as it was not returned.The kink on the guidewire measured 436mm from the proximal weld.The guidewire total length measured 451mm, which is within the specification limits of 449.2mm - 458.8mm per the guidewire product drawing.The guidewire outer diameter measured 0.61mm, which is within the specification limits of 0.610mm - 0.635mm per the guidewire product drawing.The guidewire was inserted through a lab inventory 20ga introducer needle.Resistance was encountered at the location of the kink; however, the undamaged portions of the guidewire were able to pass as expected.Performed per ifu statement, "insert tip of spring-wire guide through introducer needle into artery".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, "use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide".The report of a kinked guidewire was confirmed through analysis of the returned.A kink and overlapping coils were observed, however, the needle from the reported event was not returned.Despite the damage, the guidewire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Functional testing with a lab inventory needle revealed that kinking of this severity can lead to resistance when inserting; however, as the needle involved with this complaint was not returned, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "attempted to place right femoral groin arterial line utilizing arrow arterial catheterization 18-gauge kit.Access was obtained under ultrasound guidance but unable to thread catheter over a wire.Upon removal of catheter and wire distal tip of wire was noted to be bunched and there was a kink and wire approximately at midpoint.Patient required second attempt at femoral a-line access.Was able to successfully place second femoral access kit." there was no medical intervention required.The patient's current condition is reported as "unknown".

• 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: 21985960
• Report Number: 9680794-2025-00390
• Device Sequence Number: 12837678
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)240515(17)260531(10)33F24B0140(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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F24B0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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