BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI PAIRED WIRE HELICAL BASKET

    MDR report key: 1051089 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00530
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A GEMINI RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE IN 2008 (AGE, WEIGHT, AND GENDER ARE UNK). DURING THE PROCEDURE, THE GEMINI BASKET BROKE INSIDE THE PT AND PERFORATED THE PT'S URETER. APPROX A 10 CENTIMETER PIECE OF THE DEVICE WAS LEFT INSIDE THE PT. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN IS DECIDED WAIT FOR APPROX TWO OR THREE WEEKS TO LET THE PT HEAL BEFORE HE ATTEMPTS TO REMOVE IT. THE PHYSICIAN PLACED A STENT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PAIRED WIRE HELICAL BASKET FFL BOSTON SCIENTIFIC M0063301100 11356998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention