MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER ES GUIDE WIRE

Model Number	1011835H
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was reportedly discarded and is not returning.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 heavily calcified anterior tibial artery.During advancement of a 014 whisper extra support guide wire it met resistance with anatomy and the tip separated.It was attempted to snare the tip; however, was unsuccessful and it was decided to embed the tip into the vessel.A command guide wire was used to successfully complete the procedure.There was no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 and/or complaints reported from this lot.The investigation determined the reported difficulty to advance and tip separation appear to be related to operational circumstances of the procedure.In this case, it is likely that during advancement against resistance, the tip of the guide wire became damaged resulting in the reported tip separation.Additionally, the reported treatment appears to be related to the operational context of the procedure as unsuccessful attempts were made to snare the tip; however, the tip was embedded into the vessel.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9: updated from yes to no.

• Brand Name: HI-TORQUE WHISPER ES GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11170833
• Report Number: 2024168-2021-00445
• Device Sequence Number: 16835824
• Product Code: DQX
• UDI-Device Identifier: 08717648116117
• UDI-Public: 08717648116117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 02/28/2022
• Device Model Number: 1011835H
• Device Catalogue Number: 1011835H
• Device Lot Number: 0032671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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