BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1477603 · Received July 8, 2009

    Report

    Report Number
    3005099803-2009-03219
    Event Type
    Malfunction
    Date Received
    July 8, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 9, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAM OF THE RETURNED DEVICE FOUND THAT THE BALLOON WAS TORN CIRCUMFERENTIALLY. THE TEAR PROPAGATED HALFWAY AROUND THE BALLOON CIRCUMFERENCE AND WAS SMOOTH. ADDITIONALLY, A KINK WAS IDENTIFIED 23 CM FROM THE DISTAL TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BALLOON FAILED TO INFLATE. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED, NO ANOMALIES WERE NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE INTO THE CHOLEDOCHUS, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX RETRIEVAL BALLOON. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC CORK LTD M00546910 12453101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR