BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1180178 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04921
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STONE REMOVAL PROCEDURE, THE DISTAL PORTION OF THE EXTRACTOR RX RETRIEVAL BALLOON CATHETER SHEARED OFF INTO THE PATIENT. THE EXTRACTOR RX RETRIEVAL BALLOON WAS BEING USED IN THE COMMON BILE DUCT. THE END OF THE BALLOON CATHETER FROM THE RADIOPAQUE MARKER TO THE DISTAL END SHEARED OFF INTO THE PATIENT. ANOTHER EXTRACTOR RX RETRIEVAL BALLOON WAS USED TO REMOVE THE STONE AND THE DISTAL PORTION OF THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS, THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE - BILIARY STONE RETRIEVAL BALLOON CATHETER FGE BOSTON SCIENTIFIC CORK LTD. M00546920 11718181

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention