MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM

Model Number	1012068-06
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported difficulty was confirmed with other observations.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 did not indicate a lot specific quality issue.Factors that may contribute to difficulty removing the guide wire may include but not limited to, damaged device, anatomical conditions, device interactions or preparation technique.The investigation was unable to determine a conclusive cause for the reported difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a lesion in the mesenteric artery.The versacore guide wire could not be removed from an unspecified balloon catheter.The devices were removed as a single unit.An unspecified guide wire and new balloon catheter were used to complete the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

• Brand Name: HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10466891
• Report Number: 2024168-2020-07211
• Device Sequence Number: 16917263
• Product Code: DQX
• UDI-Device Identifier: 08717648124204
• UDI-Public: 08717648124204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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: 10/31/2021
• Device Model Number: 1012068-06
• Device Catalogue Number: 1012068-06
• Device Lot Number: 9111161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81