BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE BASKET

    MDR report key: 642128 · Received October 11, 2005

    Report

    Report Number
    6000043-2005-00082
    Event Type
    Malfunction
    Date Received
    October 11, 2005
    Date of Event
    September 30, 2005
    Report Date
    October 4, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT THE SHEATH APPEARED BROKEN WHICH ALLOWED THE BASKET TO PROTRUDE THROUGH THE SIDE OF THE SHEATH. THIS WAS NOTICED AT TIME OF PREPARATION FOR THE PROCEDURE PRIOR TO USE ON THE PT. PLEASE NOTE ASSOCIATED COMPLAINTS: 6000043-2005-0081 AND 6000043-2005-00083. THIS ISSUE WAS IDENTIFIED ON THREE DEVICES. THE PT DID NOT SUSTAIN ANY INJURY OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA HEMISPHERE BASKET STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORP. * 7663483

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other