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

Model Number	2078175
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
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 specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.The subsequent treatments appear to be related to circumstances of the procedure.Factors that may contribute to material separation include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.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 the procedure was to perform atherectomy in the posterior tibial artery.The phoenix atherectomy system and the command es guidewire were advanced to the target lesion however during use, the guide wire tip separated.A drug eluting stent was implanted to trap the separated tip in the subintimal space of the posterior tibial artery.There were no adverse patient sequela and 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: 23356942
• Report Number: 2024168-2025-11191
• Device Sequence Number: 21073978
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)250717(17)270630(10)5071771
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 10/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2078175
• Device Catalogue Number: 2078175
• Device Lot Number: 5071771
• 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: 10/13/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown