BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 786887 · Received November 22, 2006

    Report

    Report Number
    6000122-2006-00035
    Event Type
    Injury
    Date Received
    November 22, 2006
    Date of Event
    November 9, 2006
    Report Date
    November 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD
    Product Code
    FGE
    PMA / PMN Number
    k041606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN REC'D BY THIS MANUFACTURER, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A STONE REMOVAL PROCEDURE (PT'S AGE AND GENDER UNKNOWN), USING AN EXTRACTOR RX RETRIEVAL BALLOON THE BALLOON DETACHED FROM THE CATHETER. THE DETACHMENT OCCURRED IN THE COMMON BILE DUCT DURING THIS DEVICE'S INITIAL STONE REMOVAL ATTEMPT. ANOTHER EXTRACTOR RX RETRIEVAL BALLOON WAS USED TO REMOVE THE DETACHED BALLOON OUT OF THE BILE DUCT AND INTO THE DUODENUM. IT WAS LEFT THERE TO PASS NATURALLY. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE FGE BOSTON SCIENTIFIC CORK LTD M00546910 B454541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention