BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX

    MDR report key: 1651927 · Received March 31, 2010

    Report

    Report Number
    1651927
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 30, 2010
    Report Date
    March 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENTS FOR AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WERE BEING PREPARED FOR SURGERY. AS PART OF THE OR PRACTICE, THE MD ATTEMPTED TO INFLATE THE BALLOON OF THE ERCP EXTRACTOR DEVICE PRIOR TO INSERTING IT INTO THE PATIENT. THE BALLOON WOULD NOT INFLATE. THE BALLOON SYRINGE WAS EASILY DEPRESSED, BUT THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED FROM THE OPERATIVE FIELD AND REPLACED WITH AN IDENTICAL PRODUCT FROM THE SAME LOT NUMBER. THE REPLACEMENT PRODUCT FUNCTIONED AS EXPECTED. THE DEFECTIVE DEVICE HAD NO OBVIOUS FLAWS OR DEFECTS. THE STAFF DO NOT KNOW WHY THE DEVICE FAILED. THE STAFF AND MD INVOLVED IN THE CASE HAVE USED THIS DEVICE MANY TIMES. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS INCIDENT. THE ERCP RETRIEVAL BALLOON AND EXTRACTOR RX WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX CATHETER, ERCP RETRIEVAL BALLOON GBZ BOSTON SCIENTIFIC M00546900 13182519

    Patients

    Seq Age Sex Outcome Treatment
    1 *