MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Hi-Torque Winn¿ 200T Guide Wire with Turbocoat¿ Hydrophilic Coating; Wire, Guide, Catheter

Model Number	1012475
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with 99% stenosis, heavy calcification and mild tortuosity.The hi-torque winn 200 guidewire was used in the procedure.Upon removal, resistance was noted due to the heavy calcification and no guide catheter used and the distal tip detached.The detached distal segment remained within the calcified occlusion without any attempts at retrieval.The procedure was stopped and recanalization was not achieved.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.

• Brand Name: Hi-Torque Winn¿ 200T Guide Wire with Turbocoat¿ Hydrophilic Coating
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• 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--462 ; +1(951)914-5259
• MDR Report Key: 50697790
• Report Number: 2024168-2026-03492
• Device Sequence Number: 9685233
• Product Code: DQX
• UDI-Device Identifier: 08717648156908
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Model Number: 1012475
• Device Catalogue Number: 1012475
• Device Lot Number: 6032371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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: 6F introducer sheath
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown