BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX TAPERED ERCP CANNULA TAPERED TIP

    MDR report key: 1160047 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04539
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GCJ
    PMA / PMN Number
    K970054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS REPORTED FOR THE SAME LOT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN RX TAPERED ERCP CANNULA TAPERED TIP DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "DYE WAS LEAKING OUT OF THE SIDE OF THE CANNULA NEAR THE CATHETER." REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER RX TAPERED ERCP CANNULA TAPERED TIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX TAPERED ERCP CANNULA TAPERED TIP GCJ BOSTON SCIENTIFIC CORPORATION M00545770 11109290

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK