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

Catalog Number 2078175

Device Problems Material Separation (1562); Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a moderately calcified peroneal artery that is 80% stenosed.The ht command 14 guide wire was advanced and placed.Thrombectomy was performed and an unspecified balloon catheter was attempted to advance; however, met resistance with guide wire and could not advance further.When removing the guide wire the nitinol was noted to be bunched [coils under the coating].It was noted that it was noted nothing was left in the patient.A new command es gw was used successfully to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found that the proximal end of polymer coating was noted to have separated from the core.Follow up with the account confirmed that the separation of polymer coating was noticed after attempting to advance another balloon over the wire.No coating was left in the patient.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection were performed on the returned device.The reported material separation and material twisted / bent (bunching) was confirmed.The reported difficult to advance could not be tested due to the device condition.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.Factors that may contribute to difficulty advancing the balloon catheter over the wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter or guide wire.In this case, analysis of the returned wire noted bunched polymer coating, it is possible that the guide catheter interacted with the wires polymer coating, resulting in the reported difficulty during advancement and subsequent polymer bunching and separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Returned device analysis found that the proximal end of polymer coating was noted to have separated from the core.Follow up with the account confirmed that the separation of polymer coating was noticed after attempting to advance another balloon over the wire.No coating was left in the patient.No additional information was provided.

• 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: 18899222
• MDR Text Key: 337620015
• Report Number: 2024168-2024-03292
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 3091871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• 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