BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1181676 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04939
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THE DEVICE WOULD NOT CLOSE AND DEVICE DAMAGE OCCURRED. A 1.9 ZERO TIP NITINOL 120CM RETRIEVAL BASKET HAD BEEN ADVANCED TO AN UNSPECIFIED URETERAL LOCATION. THE BASKET INITIALLY FUNCTIONED NORMALLY, BUT AFTER "MULTIPLE" PASSES, THE DEVICE WOULD NOT CLOSE AROUND AN UNSPECIFIED SIZE STONE. AN UNSPECIFIED TYPE OF LASER WAS USED TO CRUSH THE REMAINING STONES. THE BASKET WAS ABLE TO BE REMOVED AND IT APPEARED "DEFORMED". THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063901050

    Patients

    Seq Age Sex Outcome Treatment
    1