MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 14 GUIDE WIRE

Catalog Number 2078175

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly calcified anterior tibial artery.The ht command es guide wire was advanced into the lesion without issues and an unspecified 2.5x30mm balloon catheter was advanced over the guide wire.The balloon catheter was used without issues; however, an attempt to remove the balloon catheter from the guide wire was made but was unsuccessful as the devices were stuck together.The balloon catheter and guide wire were removed as a unit.Once outside the patient anatomy it was noted that the hydrophilic coating on the guide wire was coming off.The procedure was successfully completed with no further devices.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned for analysis.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 difficulty removing the guide wire from the guide catheter.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during removal.Additionally, manipulation of the wire when resistance was encountered may have contributed to the reported coating damage; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE COMMAND 14 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: 18779319
• MDR Text Key: 336303547
• Report Number: 2024168-2024-02367
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: 08717648176685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2078175
• Device Lot Number: 3110371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2023
• 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: BALLOON CATHETER