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

Catalog Number 2078175

Device Problems Peeled/Delaminated (1454); Difficult to Advance (2920)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record, corrective action tracking system, and similar incident query was not performed because the lot number was not reported.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.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.

Event Description

It was reported that the procedure was to treat a severely stenotic, heavily calcified and moderately tortuous lesion in the left superior femoral artery (sfa).The ht 14 command guide wire and a non-abbott crossing catheter met resistance with the anatomy during advancement.Despite no resistance being felt on removal of the guide wire, the black polymer coating was observed to be peeling at the distal end after it was removed.The physician confirmed nothing remained in the patient and the procedure was completed with a csi atherectomy device and a viper wire.There were no adverse patient effects and there was no clinically significant delay in the procedure.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: 18337344
• MDR Text Key: 330677207
• Report Number: 2024168-2023-14085
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2078175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male