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

Catalog Number 1009664

Device Problems Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915); Difficult to Advance (2920)

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

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the coronary artery with mild calcification, heavy tortuosity and 60% stenosis.After an unspecified stent was implanted, optical coherence tomography (oct) was performed.The ht balance middleweight universal ii guide wire was advanced, but met resistance with the 6f oct catheter during advancement and removal.During removal, the polymer coating came off at the distal end.A snare device was used to retrieve the guide wire as a single unit; however, this affected the implanted stent and a new stent was placed.There were no adverse patient sequela and no clinically significant delay in the procedure.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

A visual and dimensional inspection was performed.The reported difficult to remove and difficult to advance could not be tested due to the device condition.The reported material separation was confirmed.The reported device damaged by another device could not be tested as it was based on operational context.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 identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to operational circumstances.

Event Description

Subsequent to the initially filed report, there was no polymer left in the patient.During removal of the guide wire, the previous implanted stent was deformed and unable to be attached to the vessel wall.No additional information was provided.

• 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: 18103087
• MDR Text Key: 327747751
• Report Number: 2024168-2023-12471
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1009664
• Device Lot Number: 3022873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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
• Treatment: 6F CATHETER
• Patient Outcome(s): Required Intervention