BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 844441 · Received March 2, 2007

    Report

    Report Number
    6000043-2007-00022
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUPPLIED WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. ANY INFORMATION NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA. THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A FIFTEEN (15) MONTH COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THIS PRODUCT. NO ADVERSE TREND HAS BEEN IDENTIFIED FOR THIS PRODUCT/DEVICE FAMILY WITH REGARD TO THE REPORTED FAILURE MODE.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A PATIENT (AGE AND GENDER UNKNOWN) UNDERWENT A THERAPEUTIC PROCEDURE FOR URETERAL STONE RETRIEVAL IN 2007. THE ZERO TIP NITINOL STONE RETRIEVAL BASKET "WOULD NOT WORK", IT WAS REPORTED AS 'BROKEN.' SPECIFICS TO THE BREAKAGE OF THE DEVICE COULD NOT BE CONFIRMED. ATTEMPTED USE OF A PREVIOUS DEVICE (PLEASE NOTE ASSOCIATED MEDWATCH#: 6000043-2007-00021) HAD RESULTED IN THE SAME ISSUE. NO COMPONENT OF THE DEVICE DETACHED WITHIN THE PATIENT ANATOMY. NO FORM OF INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT DID NOT SUSTAIN ANY ADVERSE EFFECT OR COMPLICATIONS AS A RESULT OF THIS ISSUE. THE PATIENT CONDITION IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL FFL BOSTON SCIENTIFIC M0063901010 9137949

    Patients

    Seq Age Sex Outcome Treatment
    1 YR