BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 2001435 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00514
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A GI RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE, THE PHYSICIAN INSERTED THE BALLOON DOWN THE ENDOSCOPE; HOWEVER, HE FELT RESISTANCE AND PULLED THE DEVICE BACK OUT OF THE ENDOSCOPE, AND THE TIP OF THE RETRIEVAL BALLOON BROKE OFF OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK UNK161

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR