BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIACTIV FX SPARE INFLATOR & SHIELDWIRE

    MDR report key: 826958 · Received February 28, 2007

    Report

    Report Number
    2530154-2007-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 28, 2007
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    NFA
    PMA / PMN Number
    K061772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KNC IS ACTIVELY PURSUING PATIENT INFORMATION AND WILL SEND IN A FOLLOW-UP REPORT IF OBTAINED. BECAUSE THE DEVICE WAS THROWN OUT BY THE HEALTH PROFESSIONAL, EVALUATION OF THE PARTICULAR DEVICE COULD NOT BE PERFORMED. HOWEVER, THERE IS AN ONGOING INVESTIGATION ON PREVIOUS COMPLAINTS THAT SHARE THE SAME FAILURE MODE. THIS EVALUATION SUMMARY WILL BE PROVIDED IN A FOLLOW-UP REPORT WHEN COMPLETED.

    Description of Event or Problem · 1

    IN 2007, ONE TRIACTIV FX KIT WAS USED TO TREAT A LESION IN AN SVG-LCX VESSEL SEGMENT. THE SHIELDWIRE WAS ADVANCED DISTAL TO THE LESION AND A STENT CATHETER WAS POSITIONED OVER THE WIRE. THE GUIDEWIRE BALLOON WAS INFLATED AND SEALED NORMALLY, CAPTURING A GOOD COLUMN OF CONTRAST. THE STENT CATHETER WAS THEN ADVANCED TO THE LESION SITE AND INFLATED. APPROXIMATELY 90 SECONDS AFTER THE PROTECTION BALLOON INFLATION, AND DURING STENT PLACEMENT, THE COLUMN OF CONTRAST DISAPPEARD INDICATING THAT THE BALLOON OCCLUSION WAS LOST. THE PROTECTION PROCEDURE WAS ABANDONED, NO FLUSH WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIACTIV FX SPARE INFLATOR & SHIELDWIRE EMBOLIC PROTECTION SYSTEM NFA KENSEY NASH CORP. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *