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

Model Number	2078173
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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 that the procedure was to treat the posterior tibial artery with severe calcification and mild tortuosity.The command guide wire was attempted to be advanced through the introducer sheath and guiding catheter; however the wire would not cross due to the anatomy.Upon removal of the guide wire, a separation occurred inside the guiding catheter.The separated piece remained in the guiding catheter and the devices were removed together as a unit.A new command guide wire was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported separation was confirmed.The reported failure to advance was not unable to be replicated in a testing environment as it was based on circumstances of the procedure.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, the investigation determined that the reported issues appear to be related to operational context of the procedure.Factors that may contribute to failure to advancing the guide wire include, but are not limited to, challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire.In this case, it is likely that the challenging anatomy contributed to the reported issue as it was reported that the command guide wire would not cross through the artery with severe calcification which likely led to the reported guide wire separation.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.

• 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: 22980089
• Report Number: 2024168-2025-09495
• Device Sequence Number: 13018703
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: (01)08717648176661(11)250221(17)270131(10)5022171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/16/2025

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: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 5022171
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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: PARENT PLUS45 53CM SHEATH.; PROMINENT ADVANCE NEO135CM GUIDING CATHETER.
• Patient Sex: Unknown