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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
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 performed to treat acute and subacute thrombosis in the femoropopliteal region.A ht command guidewire (gw) was used in combination with the non-abbott thrombectomy system; however the guidewire lost part of its hydrophilic coating.The procedure was continued with another guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H10: codes 2199 and 4582 removed.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Subsequent to the initially filed reports, additional information was provided.It was reported resistance was met when withdrawing the guide wire.The polymer coating separated and possibly remained inside the patient anatomy.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed reports, additional information was provided.It was reported resistance was met when withdrawing the guide wire.The polymer coating separated and possibly remained inside the patient anatomy.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, dimensional analysis and functional testing were performed on the returned device.The reported separation was confirmed.The reported difficult to remove was not unable to be replicated in a testing environment.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 of 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; however, the subsequent treatment appear to be related to operational context of the procedure.Factors that may contribute to difficulty removing the guide wire include, but are not limited to, inner diameter of the device used with the guide wire, outer diameter of the guide wire, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the other device used with the guide wire or guide wire which likely led to the reported polymer 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: 23402152
• Report Number: 2024168-2025-11245
• Device Sequence Number: 9946133
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)250513(17)270430(10)5051371
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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: 2078175
• Device Catalogue Number: 2078175
• Device Lot Number: 5051371
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 12/01/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: GUIDING CATHETER: SOLENT OMNI 6F CATHETER.; THROMBECTOMY SYSTEM: ANGIOJET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male