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	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left popliteal artery.A non-abbott balloon was advanced over the ht command es guide wire when resistance was noted between the devices.The balloon and guide wire were stuck together; therefore, the devices were removed as one unit.The procedure was completed with another unspecified balloon and guide wire.There were no adverse patient effects and 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
A visual inspection, functional testing, and dimensional analysis was performed on the returned device.The difficult to advance and difficult to remove could not be conformed due to the conditions of the devices and are related to case conditions and cannot be replicated in a lab environment.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 specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.It is possible the guide wire was damaged during insertion and advancement.When the catheter was advanced the damage to the guidewire likely increased the od interfering with the id of the catheter causing the difficult to advance which locked the two units together leading to the difficult to remove.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: 24044598
• Report Number: 2024168-2026-00227
• Device Sequence Number: 21117190
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)250523(17)270430(10)5052371
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 5052371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TURMO 2.0X150 BALLOON.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Hispanic