BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PILOT

    MDR report key: 6180779 · Received December 16, 2016

    Report

    Report Number
    6180779
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INTERVENTIONAL GUIDE WIRE BECAME 'LODGED' WITHIN THE BLOCKAGE OF A CORONARY ARTERY. WHEN THE PHYSICIAN PULLED BACK ON THE WIRE TO REMOVE/REPOSITION IT, THE WIRE DISASSEMBLED AND PART OF THE WIRE WAS UNRECOVERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830974 HI-TORQUE PILOT WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1010482-H 6030771

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR