BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL

    MDR report key: 1133488 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03635
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RESIDUE WAS OBSERVED ON THE RETURNED DEVICE, INDICATING IT HAS NOT BEEN USED. A VISUAL INSPECTION OF THE DEVICE FOUND THE SHEATH IS BUCKLED AND SEPARATED AT THE HANDLE. IT WAS ALSO FOUND THAT THE DISTAL 3 CM OF THE DEVICE HAS BEEN CUT OFF FROM THE REST OF THE DEVICE. THE MAJORITY OF THE BASKET AND A SMALL SECTION OF THE SHEATH ARE SEPARATED FROM THE DEVICE. THE CLEAN AND EVEN CUTS THROUGH THE SHEATH AND BASKET WIRES INDICATE THE END OF THE DEVICE WAS VERY LIKELY CUT OFF BY THE USER, AFTER THE SHEATH DAMAGE OCCURRED. CUSTOMER COMPLAINT CONFIRMED. THE RETURNED DEVICE DID NOT FUNCTION FOR THE USER DUE TO SHEATH DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED 2 DEVICES WERE SCRAPPED DURING MFG FOR BEING NONFUNCTIONAL. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. THE MAY 2008 PRODUCT FAMILY TRENDING CHART WAS REVIEWED AND DOES NOT SHOW A NEGATIVE TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON 05/22/2008 THAT ON AN UNK DATE, WHILE UNPACKING A MINI GEMINI BASKET, THE DEVICE WAS NOTICED TO BE DAMAGED. ALTHOUGH THE DEVICE WAS RETURNED WITH THE BASKET DETACHED, THE COMPLAINANT CONFIRMED THAT THE BASKET WAS NOT DETACHED WHEN SHIPPED FROM THEIR FACILITY. THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL FFL BOSTON SCIENTIFIC CORPORATION M0063303060 11135814

    Patients

    Seq Age Sex Outcome Treatment
    1