BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACHUTE STONE RETRIEVAL DEVICE

    MDR report key: 1195537 · Received October 2, 2008

    Report

    Report Number
    3005099803-2008-04991
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. 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 URETEROSCOPY PROCEDURE THE MONTH PRIOR. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS OPENED, TESTED AND FOUND TO BE WORKING. IT WAS THEN PASSED THROUGH THE SCOPE INTO THE URETER AND WOULD NOT OPEN. THE DEVICE WAS SAFELY REMOVED. COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN