BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1242901 · Received November 19, 2008

    Report

    Report Number
    3005099803-2008-06578
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ESCAPE BASKET WAS DIFFICULT TO DEPLOY. DURING PREPARATION FOR A URETEROSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING THE BASKET. IT WAS DIFFICULT TO OPEN AND CLOSE THE BASKET. IT WAS ALSO NOTED THAT ONE OF THE BASKET WIRES WAS BROKEN, BUT NOT DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE NITINOL STONE RETRIEVAL BASKET FFL - DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063902000 0011854326

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR