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

Model Number	1012068-08
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
The product was not returned to abbott vascular for analysis.Return of the guide wire may have further aided the analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query was not performed since the lot number was not reported.Factors that may contribute to the difficulty to remove the guide wire and cause resistance between the devices may include, but not limited to, device placement technique, guiding catheter support, anatomical conditions, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, condition of the balloon catheter, coagulation of blood or procedural contaminates.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.Estimated date (b)(6) 2020.
Event or Problem Description
It was reported as a general comment that versacore guide wires are difficult to remove from the balloon catheter.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: 10463661
• Report Number: 2024168-2020-07197
• Device Sequence Number: 14226015
• Product Code: DQX
• UDI-Device Identifier: 08717648124228
• UDI-Public: 08717648124228
• 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): 08/27/2020

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 Model Number: 1012068-08
• Device Catalogue Number: 1012068-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1