BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 1172014 · Received September 23, 2008

    Report

    Report Number
    MW5008385
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ABBOTT LABS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC CATH WAS COMPLETED. A 6 FRENCH SHEATH WAS LEFT IN PLACE. A JL 3.5 GUIDE WAS ADVANCED, PLACED IN THE OSTIUM OF THE LEFT MAIN. THE GUIDE WAS EXCHANGED OVER WIRE. THE SHEATH REMOVED AND AN 9 FRENCH SHEATH WAS PLACED OVER THE WIRE. AFTER WHICH AN 8 FRENCH JL 3.5 GUIDE WAS TAKEN INTO THE OSTIUM OF THE LEFT MAIN. THE FIRST BMW WIRE WAS PLACED ACROSS THE LESION OF THE LAD AND THE DISTAL LAD WITHOUT DIFFICULTY. THE SECOND BMW WIRE ADVANCED INTO THE DIAGONAL BRANCH. AFTER CROSSING THE LESION AN ATTEMPT WAS MADE TO ADJUST THE POSITION WHEN A "SNAP" WAS FELT. IT WAS NOTED THAT THE TIP OF THE WIRE WAS NOT MOVING. THOUGH THE WIRE COULD BE PULLED BACK, THE TIP REMAINED IN PLACE. THE CORE WAS BROKEN AND THE COIL WAS MOST PROBABLY STUCK IN THE DIAGONAL BRANCH LESION. THE CORE WAS REMOVED. THE COIL WAS COMPLETELY SPREAD FROM ITS COIL SHAPE. ATTEMPTS TO SNARE THE TIP WERE UNSUCCESSFUL. THE PATIENT WAS BROUGHT TO SURGERY FOR REMOVAL OF THE TIP AND BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE DQX ABBOTT LABS 1009660 8072291

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention