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

Model Number	1012475
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a chronic, totally occluded lesion in the left superficial femoral artery (sfa).The hi torque winn guide wire was being advanced and there was resistance with the anatomy, when the tip of the device sheared off into a chunk of calcification.During removal, resistance was noted with the anatomy and the windshield wiper method was used to remove the wire from the calcium.No attempts were made to retrieve the tip, it remains lodged in the calcium.The patient has been referred to a different physician for follow up.There were no adverse patient sequela.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.
Additional Manufacturer Narrative
The device was not returned for analysis.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, patient effect and subsequent treatment 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 lesion during use, resulting in the reported failure to advance.Additionally, it was reported that the guide wire tip separated during advancement.It is likely that manipulation of the wire, when resistance with the lesion was met, contributed to the reported separation.A separated tip would impact the wires maneuverability through the lesion, likely contributing to the reported difficult during removal.The separated portion of the wire was left embedded within the anatomy.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 WINN
• 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: 20964725
• Report Number: 2024168-2024-14948
• Device Sequence Number: 19882710
• Product Code: DQX
• UDI-Device Identifier: 08717648156908
• UDI-Public: (01)08717648156908(17)260430(10)4050171
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101648
• 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,Followup
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 1012475
• Device Catalogue Number: 1012475
• Device Lot Number: 4050171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male