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

Model Number	1012068-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, 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) and similar incident query for this product was not performed since the lot number was not reported.Factors that may contribute to a damaged device include, but are not limited to mishandling during manufacturing, mishandling during unpacking at the account and/or mishandling during preparation.Design and manufacturing controls have been established to mitigate possible causes.The investigation was unable to determine a conclusive cause for the reported break.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during preparation of the hi-torque versacore guide wire, the coil separated from the white part of the guide wire, the coils did not unravel.It was stated that guide wire did not separate into two pieces.There was no patient involvement.No additional information was provided.

• Brand Name: HI-TORQUE VERSACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9880126
• Report Number: 2024168-2020-02887
• Device Sequence Number: 3267834
• Product Code: DQX
• UDI-Device Identifier: 08717648124204
• UDI-Public: 08717648124204
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/25/2020

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: 1012068-06
• Device Catalogue Number: 1012068-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1