BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI-FLEX NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1234087 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05938
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. BSC REF: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OPTI-FLEX NITINOL STONE RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY WITH LASER LITHO PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, ONE OF THE WIRES ON THE BASKET BROKE. THEY WERE ABLE TO MAKE 10 PASSES WITH THIS BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME TYPE DEVICE AND THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FLEX NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORPORATION M0063903010 11987072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK