BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1392956 · Received May 27, 2009

    Report

    Report Number
    3005099803-2008-03444
    Event Type
    Malfunction
    Date Received
    May 27, 2009
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED IN A PROCEDURE (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE DOCTOR WAS USING THE BALLOON TO SWEEP THE CDB WHEN THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE FGE BOSTON SCIENTIFIC CORK LTD. M00546910 11325798

    Patients

    Seq Age Sex Outcome Treatment
    1