BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1161569 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04530
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO CONTACT BETWEEN THE BALLOON AND A SHARP EXTERIOR SOURCE SUCH AS A SHARP, IRREGULAR STONE DURING STONE EXTRACTION.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 3005099803-2008-04529. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, BALLOON DAMAGE OCCURRED. THE STONES WERE LOCATED IN THE COMMON BILE DUCT (CBD). THE EXTRACTOR RX 12MM X 15MM RETRIEVAL BALLOON WAS ADVANCED TO THE CBD, HOWEVER, UPON SWEEPING THE DUCT, THE BALLOON "POPPED". THE DEVICE WAS REMOVED INTACT. ANOTHER OF THE SAME DEVICE WAS ADVANCED, HOWEVER, UPON SWEEPING THE DUCT THIS BALLOON "POPPED" AS WELL. THE DEVICE WAS REMOVED IN TACT. A THIRD OF THE SAME DEVICE WAS USED IN CONJUNCTION WITH AN UNSPECIFIED TRAPEZOID BASKET TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546910 11786888

    Patients

    Seq Age Sex Outcome Treatment
    1