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

Model Number	1060002A
Medical Device Problem Codes	Break (1069); 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
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported difficulty to advance was not confirmed.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 specific issue.Based on the information provided and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.Factors that may contribute to difficulty advancing the catheter over the guide wire include, but are not limited to, inner diameter of the catheter, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the catheter or guide wire which likely led to the observed damages to the polymer coating and observed bent in the core.The observed scratched teflon coating was not reported and likely occurred due to interaction with the torque device being tight against the guide wire.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the patient had an occlusion in the pedal area.The ht command 14 st 300 was advanced to dorsalis pedis artery, and the wire crossed the occlusion.A non-abbott 2.5 x 200 mm balloon dilatation catheter was advanced over the command wire until it reached 3-4 cm before the tip of the wire.At this point the physician felt resistance and had difficulty in maneuvering the wire.The command wire was exchanged for a non-abbott guide wire with no problem.The procedure was successfully finished.There were no adverse patient effect and no clinically significant delay in the procedure.The returned device was broken at the distal solder ball.The customer believes that the observed damage occurred during the procedure and this was causing the resistance felt during advancement.It was thought that it was somehow caused by the interaction between the command wire and the 2.5 x 200 mm non-abbott balloon dilatation catheter.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: 24489858
• Report Number: 2024168-2026-00852
• Device Sequence Number: 5016922
• Product Code: DQX
• UDI-Device Identifier: 08717648356841
• UDI-Public: (01)08717648356841(17)270630(10)5072871
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K240997
• 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
• Report Date (Section B): 03/02/2026

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: 1060002A
• Device Catalogue Number: 1060002A
• Device Lot Number: 5072871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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