BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE NITINOL STONE RETRIEVAL BASKET

    MDR report key: 2153328 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02162
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE (B)(6) 2008, 15-MONTH RADIAL JAW 4-FORCEPS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    AN ESCAPE BASKET WAS USED DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN TESTING THE DEVICE PRIOR TO PLACING IT IN THE PT, THE BASKET WOULD NOT ENGAGE. THEY COULD NOT OPEN OR CLOSE THE BASKET FROM THE HANDLE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORPORATION M0063902010 9356445

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK