MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WINN GUIDE WIRES

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	02/21/2023
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 to treat a chronic total occlusion (cto) in the anterior tibial artery with heavy calcification.The 014 winn 80 300cm guidewire (gw) was attempted to be advanced to the target lesion; however, when torqueing the gw 10mm of the tip snapped off in the occluded vessel and the tip of the gw became embedded in the vessel.Due to the vessel being totally occluded there was no attempt to retrieve the separated gw tip; therefore, the tip of the gw remained embedded in the vessel and no further treatment was performed.There was no adverse patient sequela.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 lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The guide wire was returned with the core, tip coils, polymer coating, and the tip solder were separated distal to end of the proximal end of the polymer coating, confirming the reported material separation.The distal separated portion of the core, tip, the polymer coating, and the tip solder were not returned.The polymer material at the separation was jagged, stretched and torn.In this case, it is possible that the guide wire interacted with the patient¿s heavily calcified anatomy during advancement, resulting in the reported failure to advance.Manipulation of the guide wire during its interaction with the anatomy may have contributed to the reported tip separation and noted stretched coils; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.In this case, it is possible that the guide wire interacted with the patient¿s heavily calcified anatomy during advancement, resulting in the reported failure to advance.Manipulation of the guide wire during its interaction with the anatomy may have contributed to the reported tip separation and noted stretched coils; however, this cannot be confirmed.Additionally, the separated portion of the guide wire was embedded in a vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE WINN GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 16553839
• Report Number: 2024168-2023-02739
• Device Sequence Number: 3021463
• Product Code: DQX
• UDI-Device Identifier: 08717648156847
• UDI-Public: 08717648156847
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/26/2023

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: 09/30/2023
• Device Model Number: 1012469
• Device Catalogue Number: 1012469
• Device Lot Number: 1102971
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 44 KG