BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1584315 · Received January 19, 2010

    Report

    Report Number
    3005099803-2010-00180
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    December 31, 2009
    Report Date
    December 31, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. 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 INFO RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED FOR A URETEROSCOPY PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, THE COIL OF THE DEVICE WAS "SEVERED" IN THE UPPER POLE OF THE PT'S KIDNEY. NO OTHER DEVICE PROBLEMS WERE NOTICED. THE COIL WAS NOT RETRIEVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITHOUT AN ADDITIONAL DEVICE. ALTHOUGH A HOLMIUM LASER WAS USED DURING THE PROCEDURE, IT HAS NOT BEEN CONFIRMED THAT IT CAUSED THE COIL TO DETACH. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL FGO BOSTON SCIENTIFIC CORPORATION M0063903100 0000678413

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other