MAUDE Adverse Event Report: ABBOTT VASCULAR HT WINN GUIDE WIRE

Model Number	1012475
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified de novo superficial femoral artery that was 100% stenosed.A hi-torque winn 200t guide wire was advanced subintimal with resistance due to anatomy and when pulled back, the wire tip broke off and was left in the patient.After ballooning the artery, the separated tip was jailed in with a supera stent.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned unit.The separation was confirmed.The failure to advance could not be tested as it was based on procedural circumstances.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.Based on the information provided, the investigation determined that the reported failure to advance, material separation, observed stretched/twisted/bent material and the device embedded in vessel appear to be due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT WINN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10420569
• Report Number: 2024168-2020-06856
• Device Sequence Number: 2713949
• Product Code: DQX
• UDI-Device Identifier: 08717648156908
• UDI-Public: 08717648156908
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 02/28/2021
• Device Model Number: 1012475
• Device Catalogue Number: 1012475
• Device Lot Number: 9031471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 41