BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASOBILIARY TUBE (WITH JAGWIRE)

    MDR report key: 1053265 · Received May 28, 2008

    Report

    Report Number
    3005099803-2008-00566
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K982508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED, BUT THE DEVICE EVALUATION IS NOT COMPLETE; THEREFORE, THE CAUSE OF THE REPORTED TIP DAMAGE AND DETACHMENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR THIS LOT. THE APRIL 2008 15- MONTHS NASOBILIARY CATHETERS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A NASOBILIARY TUBE (WITH JAGWIRE) WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN AN ADULT FEMALE PT IN 2008. ACCORDING TO THE COMPLAINANT, AS THE GUIDEWIRE WAS RETRACTED FROM THE CANNULA, THE TIP WAS "TORN AND PEELED." THE DAMAGED TIP DETACHED FROM THE GUIDEWIRE, AND MOVED INTO THE CYSTIC DUCT. THE PHYSICIAN DID NOT REMOVE THE GUIDEWIRE TIP, AND IT WAS "ELIMINATED SUCCESSFULLY" FROM THE DUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NASOBILIARY TUBE (WITH JAGWIRE) DEVICE. THERE WERE NO PT COMPLICATIONS, AND THE PT'S CONDITION WAS REPORTED AS "GOOD" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASOBILIARY TUBE (WITH JAGWIRE) FGE BOSTON SCIENTIFIC CORPORATION M00540650 9032847

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK