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

Model Number	2078175
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive 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 level product quality issue.As there was no damage noted to the device during the inspection prior to use, it is possible that interaction with the moderately calcified and mildly tortuous anatomy/other devices and/or a build-up of procedural contaminants (blood, contrast) on the guide wire contributed to the reported difficult to advance and the reported difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the tibial and popliteal arteries with moderate calcification and mild tortuosity.The hydrophilic coating of the command 14 guide wire core and tip was thought to have stripped off due to the resistance noted during advancement.The wire became entrapped within an unspecified balloon catheter.As a result, the command guide wire and balloon were removed together.A non-abbott wire was used to complete the procedure.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 23074302
• Report Number: 2024168-2025-09905
• Device Sequence Number: 9812563
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)240315(17)260228(10)4031571
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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 Expiration Date: 02/28/2026
• Device Model Number: 2078175
• Device Catalogue Number: 2078175
• Device Lot Number: 4031571
• 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: 08/28/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED BALLOON CATHETER.
• Patient Sex: Unknown