BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1070473 · Received July 7, 2008

    Report

    Report Number
    3005099803-2008-01067
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED ENDOSCOPIC PROCEDURE, A BALLOON BURST OCCURRED. AN EXTRACTOR RX 12-15MM ABOVE RETRIEVAL BALLOON HAD BEEN SELECTED AND ADVANCED TO AN UNSPECIFIED DUODENAL LOCATION. DURING THE PROCEDURE, THE BALLOON BURST AND LEFT SHREDS OF LATEX MATERIAL IN THE DUODENUM. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. DESPITE MULTIPLE ATTEMPTS TO REQUEST ADDITIONAL INFORMATION, NO INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546910 11650476

    Patients

    Seq Age Sex Outcome Treatment
    1