BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1180964 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04917
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE DEFLATION ISSUES OCCURRED. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). AN EXTRACTOR RX 9 - 12 MM RETRIEVAL BALLOON HAD BEEN SELECTED TO TREAT THE TARGET LESION. WHILE PREPARING THE DEVICE, THE DEVICE WAS INFLATED OUTSIDE THE PATIENT'S BODY AND IT WAS NOTICED THAT THE DEVICE "TOOK LONGER TO DEFLATE". THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546900

    Patients

    Seq Age Sex Outcome Treatment
    1