BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1053262 · Received May 28, 2008

    Report

    Report Number
    3005099803-2008-00562
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED RELATED TO THIS FAILURE MODE. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. THE SUSPECT DEVICE, SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A 35MM SECTION OF THE DISTAL END OF THE SHEATH HAD SEPARATED FROM THE REMAINDER OF THE SHEATH. THE BASKET OF THE DEVICE IS BENT AND KINKED AT THE PROXIMAL END OF THE BASKET. THE BROKEN ENDS OF THE SHEATH AND THE AREA NEAR THE BREAK WERE FOUND TO HAVE A MELTED APPEARANCE. IT IS LIKELY THAT THE SHEATH BROKE AT THIS LOCATION DUE TO OVERHEATING THAT CAUSED THE SHEATH TO MELT AND BECOME WEAK. THE SOURCE OF HEAT IS UNK. THE EVENT INFO DOES NOT STATE THAT A LASER WAS USED, WHICH IS THE MOST LIKELY SOURCE FOR HEAT.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A URETEROSCOPY WAS PERFORMED TO EXTRACT A STONE USING A SEGURA HEMISPHERE STONE RETRIEVAL BASKET. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SEGURA HEMISPHERE STONE RETRIEVAL BASKET WOULD NOT OPEN. WHEN THE PHYSICIAN TRIED TO OPEN THE BASKET A LONG PIECE OF SHEATH, APPROX AN INCH AND A HALF LONG, SEPARATED FROM THE BASKET. THE PHYSICIAN RETRIEVED THE PIECE OF THE SHEATH WITH A GRASPER. REPORTEDLY, THERE WERE NO COMPLICATIONS AND THE PT WAS FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA HEMISPHERE STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORPORATION M0063801060 11360279

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK