BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT 200 GUIDEWIRE

    MDR report key: 3961008 · Received July 23, 2014

    Report

    Report Number
    MW5037426
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ABBOTT
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ABBOTT PILOT 200 GUIDEWIRE REF NUMBER (B)(4), LOT NUMBER 4022271. HYDROPHYLIC TIP OF GUIDEWIRE SEPARATED FROM THE BODY OF THE GUIDEWIRE AND LODGED IN LEFT CIRCUMFLEX CORONARY ARTERY. REQUIRED EXTENDED PROCEDURE TIME AND RADIATION DOSE TO REMOVE GUIDEWIRE TIP. GUIDEWIRE TIP RETRIEVED WITH AN EV3 AMPLATZ GOOSE NECK MICROSNARE KIT REF NUMBER (B)(4). DIAGNOSIS OR REASON FOR USE: TO OPEN OCCLUDED CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432100 HI-TORQUE PILOT 200 GUIDEWIRE NONE DQX ABBOTT 1010485-H 4022271

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention