BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCATCH IMMOBILIZATION DEVICE

    MDR report key: 1844882 · Received September 27, 2010

    Report

    Report Number
    3005099803-2010-04063
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A LITHOCATCH IMMOBILIZATION DEVICE WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ONE BASKET WIRE WAS NOTICED TO BE BROKEN DURING PREPARATION, OUTSIDE THE PATIENT. THE BROKEN WIRE DID NOT DETACH FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCATCH IMMOBILIZATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCATCH IMMOBILIZATION DEVICE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - SPENCER M0068404120

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR