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); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified, moderately tortuous, and chronically occluded lesion in the left anterior tibial artery.The command 14 st guide wire was advanced with difficulty due to the anatomy.After approximately 30 minutes advancing, the guide wire tip did a very tiny loop.The physician forced the wire to straighten by pulling it into the armada 14 catheter.The tip coils stretched out at the loop section and the core separated but the guide wire was still in one piece.The guide wire went into the armada14 xt guidewire lumen and was removed from the patient.The procedure was completed using balloon angioplasty.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported break was able to be confirmed.The reported material too soft / flexible was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified, moderately tortuous, and chronically occluded anatomy resulted in the reported difficult to advance.Interaction with the heavily calcified, moderately tortuous, and chronically occluded anatomy inadvertently resulted in the reported prolapse (tip did a very tiny loop).Interaction and/or manipulation as the compromised guide wire was forcibly straightened by pulling it into the armada 14 catheter resulted in the reported/noted stretched coils and ultimately resulted in the reported core separation/noted core and polymer separations.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.

• 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: 22226806
• Report Number: 2024168-2025-06204
• Device Sequence Number: 12850965
• Product Code: DQX
• UDI-Device Identifier: 08717648356841
• UDI-Public: (01)08717648356841(17)270228(10)5032171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 07/22/2025

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 Model Number: 1060002A
• Device Catalogue Number: 1060002A
• Device Lot Number: 5032171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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: ARMADA 14 XT BALLOON CATHETER
• Patient Sex: Unknown