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

Model Number	1012475
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat heavily calcified proximal popliteal artery.An attempt to advance the.014 hi-torque winn guide wire was made; however, met resistance with anatomy causing the tip became stuck in the patient's anatomy and separate.The tip remained lodged in the anatomy and no intervention was made to remove the tip.The rest of the guide wire was simply withdrawn with no resistance felt during removal.A new device was used to continue and successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.There was no additional information provided.
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
Subsequently, after the initial report it was noted that the winn guide wire failed to cross.No additional information was provided.
Additional Manufacturer Narrative
A visual 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 effect appear to be related to the operational context of the procedure.It was reported that the guide wire failed to cross due to interaction with the patient¿s heavily calcified lesion.Manipulation of the guide wire, when resistance was encountered, likely contributed to the reported material separation.Analysis of the returned wire noted the separation point to be jagged, this type of damage is consistent with manipulation of the wire against resistance.The separated portion of the wire remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.E1 correction: first, last name updated from unk to (b)(6).E1 correction: title updated from unk to dr.H6 correction: medical device problem code 2920 removed and 2524 added.

• 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: 19818894
• Report Number: 2024168-2024-08742
• Device Sequence Number: 8679809
• Product Code: DQX
• UDI-Device Identifier: 08717648156908
• UDI-Public: (01)08717648156908(17)240831(10)2092071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/22/2024

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: 08/31/2024
• Device Model Number: 1012475
• Device Catalogue Number: 1012475
• Device Lot Number: 2092071
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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 Sex: Unknown