MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number 1009664J

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

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

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3, b6: dates estimated.

Event Description

It was reported that the ht balance middleweight universal ii guide wire was advanced until the subclavian artery; however, remained stuck in an arterial loop between humeral and radial arteries.It was noted that the device eventually separated and the distal portion was retrieved via snare through femoral access.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported difficult to advance and difficult to remove could not be tested due to the device condition.The reported material separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the reported treatment appears to be related to operational context.In this case, analysis of the returned device noted the guide wire was kinked in the shaping ribbon and there were stretched coils at the kink.The stretched coils indicate manipulation against resistance.It is possible that the guide wire became damaged during use, resulting in the kink.The kink possibly contributed to the noted resistance during advancement and removal, resulting in the noted stretched coils.Manipulation of the guide wire, when resistance was encountered, possibly contributed to the reported material separation.This is supported by the return analysis, which discovered the fracture face of the separation to be bent and jagged.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18581314
• MDR Text Key: 333742385
• Report Number: 2024168-2024-01101
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648118753
• UDI-Public: 08717648118753
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1009664J
• Device Lot Number: 2120171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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
• Patient Outcome(s): Required Intervention