BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACHUTE STONE RETRIEVAL DEVICE

    MDR report key: 1190748 · Received October 6, 2008

    Report

    Report Number
    3005099803-2008-05077
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH EXPECTED, THE SUSPECT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION, THUS, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A PARACHUTE STONE RETRIEVAL DEVICE WAS USED DURING A STONE RETRIEVAL PROCEDURE THE PREVIOUS DAY. ACCORDING TO THE COMPLAINANT, THE BASKET WAS UNABLE TO BE OPENED TO CAPTURE THE STONE. WHEN THE DEVICE WAS EXAMINED, IT WAS NOTED THAT THE OUTER SHEATH, VERY CLOSE TO THE HANDLE, HAD AN ACCORDIAN TYPE DEFORMITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WERE NO REPORTED PT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARACHUTE STONE RETRIEVAL DEVICE FFL BOSTON SCIENTIFIC CORPORATION M0063203020 7983545

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK