BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI?

    MDR report key: 4233287 · Received November 6, 2014

    Report

    Report Number
    3005099803-2014-03591
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER ABLATING THE STONE THE PHYSICIAN ATTEMPTED TO CAPTURE THE STONE WITH THE GEMINI RETRIEVAL BASKET. TWO BASKET WIRES AT THE DISTAL END BROKE, BUT WERE STILL ATTACHED. THE BROKEN WIRES STUCK INTO THE CALYX OF THE KIDNEY. THE PHYSICIAN MANEUVERED THE BASKET FOR 30 MINUTES AND WAS ABLE TO REMOVE THE BASKET WITHOUT CAUSING ANY ADDITIONAL DAMAGE TO THE PATIENT. THE STONE WAS LEFT TO PASS NATURALLY. IT IS UNKNOWN IF THE BASKET CAME IN CONTACT WITH THE LASER DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712762 GEMINI? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063301080 16414842

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR