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

Model Number	2078173
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the right popliteal artery with heavy calcification.The ht command 300cm guide wire (gw) was inserted in a sheath and was attempt to be advanced to cross the target lesion; however, the gw failed to cross due the anatomy.Therefore, the gw was removed from the patient and the polymer coating was noted to have peeled back from the gw.Another ht command guide wire (gw) was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.E1 facility name: (b)(6) hospital.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported peeled / delaminated was confirmed as polymer separation.The reported failure to advance could not be tested as it was based on operational context.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the guide wire interacted with the patient¿s heavily calcified and 90% stenosed lesion, resulting in a failure to advance.Additionally, it was reported that the polymer was noted to be peeled after use.Analysis of the returned wire confirmed the peeled polymer as polymer separated, stretching, and bunching.It is likely that manipulation of the wire, when resistance was met, contributed to the polymer damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 21351407
• Report Number: 2024168-2025-01501
• Device Sequence Number: 18106414
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: (01)08717648176661(17)260531(10)4061371
• 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): 03/10/2025

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 Expiration Date: 05/31/2026
• Device Model Number: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 4061371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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