BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    MDR report key: 1972525 · Received December 30, 2010

    Report

    Report Number
    3005462046-2010-00035
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 10, 2010
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K100303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER BALLOON SEPARATION OCCURRED AND WAS DETACHED PRIOR TO USE IN PT AND THE CATHETER WAS NOT USED IN A PT. THUS, THERE WAS NO PT INVOLVEMENT. EVAL SUMMARY: VISUAL EXAMINATION OF THE RETURNED CATHETER FOUND THAT THE BALLOON WAS SEVERED AT THE MID SECTION. TWO OF THE SCORING ELEMENT STRUTS WERE SEVERED. THE DISTAL BALLOON SECTION AND PROXIMAL BALLOON SECTION WERE HELD TOGETHER BY ONE SCORING ELEMENT STRUT. THERE WAS A CLEAN CUT OBSERVED ON THE BALLOON. THERE WAS PRESENCE OF BLOOD INSIDE THE INFLATION LUMEN OF THE CATHETER. RESULTS: THE CATHETER BALLOON SEPARATION WAS REPORTEDLY OBSERVED AS THE DEVICE WAS REMOVED FROM ITS PACKAGING.

    Description of Event or Problem · 1

    WHEN THE DEVICE WAS PULLED FROM THE PACKAGING, THE SHAFT UNDER THE BALLOON WAS SEVERED IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTA SCORING BALLOON CATHETER LIT ANGIOSCORE, INC. 2039-2520 F09070008

    Patients

    Seq Age Sex Outcome Treatment
    1