MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE COMMAND¿; WIRE, GUIDE, CATHETER

Model Number	2078175
Medical Device Problem Codes	Break (1069); Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the femoropopliteal segment of the left leg.There was no high-grade stenosis, although there was greater tortuosity in the left femoral artery where the femoral access was performed.The target zone was treated with the stealth 360 atherectomy, followed by angioplasty using unspecified armada balloons and the viperwire was used.Finally, upon withdrawing the viperwire together with the catheter, the guidewire fractured into two parts.The coil detached and lodged in the distal portion of the popliteal segment, while the other two fragments remained inside the stealth 360 catheter.As a result, when the catheter was completely removed, nothing was left behind except the coil tip.As a rescue measure, a "lazo" was used to capture and extract the tip and dissections were noted at this time.Due to this rescue maneuver, the command es guide wire was introduced to maintain access.The tip of the command es guide wire unraveled during the procedure and the coils were noted to be broken.The area was stented with two unspecified supera self expanding stents to treat the dissections produced during the rescue, thus completing the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.Based on the information received, the investigation determined that the reported issue appears to be related to operational context.It appears likely that the guide wire became damaged (break in the core & deformation) during insertion or during the lesion treatment procedure.In certain circumstances, such as manipulation through tortuous and/or tight lesions, where heavy torquing and/or pushing/pulling is required, damage to a wire including a break may occur.Additionally, tortuosity may have damaged the device during advancement.Once the core breaks the unraveling of the coil (stretch) can occur.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE COMMAND¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 23771843
• Report Number: 2024168-2025-11951
• Device Sequence Number: 21263151
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)250303(17)270228(10)5030372
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2078175
• Device Catalogue Number: 2078175
• Device Lot Number: 5030372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown