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

Model Number	1012469
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/16/2024
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 resistance was met with the winn guidewire and the challenging anatomy.Approximately 3 mm of the guidewire tip broke during advancement with resistance to the heavily calcified, mildly tortuous, 100% stenosis lesion and chronic total occlusion (cto) in the right posterior tibial artery.The separated tip remains lodged in the cto lesion.There were no adverse patient sequelae.An ht command es guidewire was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.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 and subsequent patient effects appear to be related to the operational context of the procedure.It was reported that the guide wire met resistance with the patient¿s heavily calcified, mildly tortuous, and 100% stenosed lesion during advancement, resulting in the reported failure to advance.Additionally, it was reported that the guide wire separated during advancement.Analysis of the returned wire confirmed the separation.The separated face was noted to be jagged, indicating manipulation at a kink or bend.The analysis also noted, stretched/ misaligned coils and a bent distal core.These types of damages are consistent with interaction with challenging anatomy.It is likely the wire sustained damage during advancement, contributing to the reported material separation.The separated portion remains embedded within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Correction b2 outcomes: removed "required intervention".Replaced it with "other serious".

• 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: 19923652
• Report Number: 2024168-2024-09312
• Device Sequence Number: 15264990
• Product Code: DQX
• UDI-Device Identifier: 08717648156847
• UDI-Public: (01)08717648156847(17)250331(10)3040671
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 09/13/2024

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: 03/31/2025
• Device Model Number: 1012469
• Device Catalogue Number: 1012469
• Device Lot Number: 3040671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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; Required Intervention
• Patient Sex: Unknown