MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Catalog Number 1013785

Device Problems Material Separation (1562); Insufficient Information (3190)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the superficial femoral artery (sfa) with heavy calcification.Prior to reaching the lesion in the subintimal artery the nitinol portion of the gw separated.An additional ht command guidewire was returned for device analysis.Return device analysis found the polymer coating, core and coils were separated approximately 12.6 centimeters (cm) distal to the proximal end of the polymer coating.The separated distal portion of the polymer coating, core and coils, including the tip ball, were returned with bent core.The polymer coating material at the separation was stretched, torn, twisted and uneven.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.B3: the first ht command referenced in b5 is filed under a separate medwatch report number.

Event Description

Subsequent to initial reports being filed it was reported that the procedure was to treat the superficial femoral artery (sfa) with heavy calcification.Prior to reaching the lesion in the subintimal artery the nitinol portion of the gw separated.An additional ht command guidewire was returned for device analysis.Return device analysis found the polymer coating, core and coils were separated approximately 12.6 centimeters (cm) distal to the proximal end of the polymer coating.The separated distal portion of the polymer coating, core and coils, including the tip ball, were returned with bent core.The polymer coating material at the separation was stretched, torn, twisted and uneven.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The electronic lot history record / device history record and exception review were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the noted issue.Analysis of the returned device noted a material separation.At the separation the core was bent and the polymer coating was torn, this suggests the tip separated due to force applied.It is possible that the guide wire was manipulated against resistance, resulting in the separation; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE COMMAND 18 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18983205
• MDR Text Key: 338669466
• Report Number: 2024168-2024-03701
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648212406
• UDI-Public: (01)08717648212406(17)250831(10)3090761
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K152404
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013785
• Device Lot Number: 3090761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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