MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-1/2"; WIRE GUIDE CATHETER

Catalog Number RA-04220

Device Problems Unraveled Material (1664); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The report of an unraveled guide wire was confirmed through complaint investigation.The guide wire was observed to be unraveled towards the distal end.Despite the damage, the guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Regardless of these circumstances, the root cause cannot be determined without the catheter and catheterization device also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.The ifu provided with the kit informs the user, "to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel".

Event Description

It was reported that: the rrt was attempting to insert a radial arterial line in the ccu using the above-named guidewire set.She c hecked the set for the ability to withdraw the guidewire prior to starting the procedure, as per policy.She inserted the needle into the patient's wrist area and obtained arterial blood flash in the viewing window, indicating that the needle was correctly placed in the patient's artery.She advanced the guidewire without issue but then was unable to advance the catheter over the needle.She attempted to withdraw the guidewire prior to removing the needle and discontinuing the attempt, however she felt significant resistance when attempting to withdraw the guidewire.Despite careful repositioning, she was still experiencing resistance from the guidewire and managed to withdraw the wire against the resistance.When the guidewire was removed it had split into two pieces and had a curled and slightly unraveled appearance.There was no evidence of hematoma or injury at the site.After the procedure was completed, she notified the mrp, who determined it best to complete a ct scan of the patient's arm to determine whether there were any fragments left behind.Fortunately, there was nothing visualized and there appears to be no other sequelae of this event.The patients curr ent condition is reported as fine.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2"
• Type of Device: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18874813
• MDR Text Key: 337324256
• Report Number: 9680794-2024-00221
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00801902002761
• UDI-Public: 00801902002761
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F23K0192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1