MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING

Model Number	28000
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
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 heavily calcified left anterior descending (lad) artery.Access was gained via the groin, and the 014 hi-torque balance guide wire (gw) was advanced towards the lesion but before it reached the lad, it became caught on the heavily calcified anatomy and could not cross.During removal of the gw, resistance was met with the anatomy again and the coils became stretched and unraveled, but was removed in one piece.Another unspecified guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned guide wire.The reported stretched coils were confirmed.The reported failure to advance and difficulty to remove was unable to be replicated in a testing environment as it was based on operational 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 and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, stretched coils and difficulty to remove appears to be related to operational circumstances of the procedure.Based on the reported information, during advancement the guide wire encountered resistance with the heavily calcified anatomy causing the failure to advance and difficulty to remove.Manipulation against resistance during retraction caused the tip coils to stretch.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11467816
• Report Number: 2024168-2021-01975
• Device Sequence Number: 11723495
• Product Code: DQX
• UDI-Device Identifier: 08717648013423
• UDI-Public: 08717648013423
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• 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): 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 28000
• Device Catalogue Number: 28000
• Device Lot Number: 0071471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 89