BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1033837 · Received April 25, 2008

    Report

    Report Number
    2024168-2008-00353
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: GUIDE WIRE TIP SEPARATED AND REMAINS IN THE PT. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT WHILE INSERTING AN LV LEAD VIA A CORONARY SINUS FOR A BIVENTRICULAR PACEMAKER, THE LV LEAD WAS PROVING VERY DIFFICULT TO GET INTO THE RIGHT POSITION. AN ATTEMPT WAS MADE WITH A BMW UNIVERSAL GUIDE WIRE; HOWEVER, WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDE WIRE, IT MET RESISTANCE. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE GUIDE WIRE FURTHER AND WITHDRAW, WHEN THE TIP OF THE GUIDEWIRE SEPARATED AND REMAINED IN THE EPICARDIAL RANGE. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6020153

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability OTHER: LV LEAD