BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCATCH IMMOBILIZER DEVICE

    MDR report key: 1369455 · Received January 27, 2009

    Report

    Report Number
    3005099803-2009-00312
    Event Type
    Malfunction
    Date Received
    January 27, 2009
    Report Date
    January 8, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MANUFACTURE AND EXP DATES CANNOT BE DETERMINED. THIS DEVICE HAS BEEN RECEIVED, BUT AN EVAL HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. WE ARE NOT ABLE TO AT THIS TIME TO DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THE EVENT. IF THERE IS ANY FURTHER RELEVANT INFO RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING THE PREPARATION TO PERFORM A THERAPEUTIC CALCULUS REMOVAL FROM A PT. THE BASKET WAS UNABLE TO BE RETRACTED INTO THE SHEATH. THE BASKET WAS OUTSIDE THE PT WHEN THIS PROBLEM OCCURRED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE EVENT DATE. THE CLINICIANS THEN OBTAINED ANOTHER BASKET AND SUCCESSFULLY COMPLETED THE PT PROCEDURE. THE COMPLAINANT REPORTED THAT THERE WERE NO PT COMPLICATIONS AS A RESULT OF THIS REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCATCH IMMOBILIZER DEVICE FGO BOSTON SCIENTIFIC CORPORATION M0068404120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK