MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL LINE KIT; WIRE GUIDE CATHETER

Catalog Number	AK-04510-S
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medwatch report # mw5119230.
Event or Problem Description
Medwatch report received: "unknown age - after achieving arterial flow in the left femoral artery with an 18g needle, the wire was introduced, but when attempting to remove the needle, there was a snagging sensation over the wire, so the wire was then attempted to be removed through the needle without success, again with a sensation of snagging.The wire and needle were then removed together, and upon removing the majority of the wire came out of the puncture site, however the wire appeared to have partially unraveled, and metal threads were still stuck within the vascular puncture site, still attached to the wire.It appears that the wire shredded somehow during this process, though the mechanism is unclear.Wires should be able to be inserted and removed through the needle without damage to the wire.The metal threads were removed from the vascular access site.The main concern was how the metal threads were shredded off the wire.".
Event or Problem Description
Medwatch report received: "unknown age - after achieving arterial flow in the left femoral artery with an 18g needle, the wire was introduced, but when attempting to remove the needle, there was a snagging sensation over the wire, so the wire was then attempted to be removed through the needle without success, again with a sensation of snagging.The wire and needle were then removed together, and upon removing the majority of the wire came out of the puncture site, however the wire appeared to have partially unraveled, and metal threads were still stuck within the vascular puncture site, still attached to the wire.It appears that the wire shredded somehow during this process, though the mechanism is unclear.Wires should be able to be inserted and removed through the needle without damage to the wire.The metal threads were removed from the vascular access site.The main concern was how the metal threads were shredded off the wire.".
Additional Manufacturer Narrative
(b)(4) complaint verification testing 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 customer description states that the guide wire was attempted to be retracted back through the needle after advancing.This directly contradicted the product ifu, which explicitly cautions the user against withdrawing the guide wire against the needle bevel while in the vessel.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, use error likely caused or contributed to this event.An in-service has been requested to instruct the customer on proper use of the device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL LINE KIT
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17497225
• Report Number: 9680794-2023-00564
• Device Sequence Number: 6374661
• Product Code: DQX
• UDI-Device Identifier: 20801902121688
• UDI-Public: 20801902121688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: AK-04510-S
• Device Lot Number: 33F23B0292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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