BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1221539 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-05919
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #3005099803-2008-06051. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THAT A KINK OCCURRED. THE TARGET LESIONS WERE SEVERAL 0.5 CM STONES IN THE LEFT INTRAHEPATIC DUCT. AN EXTRACTOR RX 15-18 MM RETRIEVAL BALLOON CATHETER HAD BEEN ADVANCED TO THE TARGET LESION, BUT WOULD NOT ADEQUATELY CROSS THE LESIONS. AN AUTOTOME RX 44-20MM WAS THEN SELECTED. THE AUTOTOME WAS EXAMINED PRIOR TO INSERTION AND THE TIP WAS INTACT. THE PHYSICIAN MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO CROSS THE TARGET LESIONS WITH THE AUTOTOME. THE DEVICE WAS REMOVED AND A 0.3CM CRACK WAS FOUND AT THE PLASTIC TIP. THE EXTRACTOR RX 15-18MM WAS THEN RESELECTED FOR USE. THE DEVICE WAS ABLE TO CROSS THE LESIONS. A NEW AUTOTOME RX 44-20MM WAS USED FOR SPHINCTEROTOMY. THE EXTRACTOR RX 15-18MM WAS AGAIN INSERTED, BUT WAS UNABLE TO ADEQUATELY CROSS, AS A KINK AT 3CM FROM THE TIP OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX 15-18MM . THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546920 0011890792

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR