BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIFLEX? RX DELIVERY SYSTEM

    MDR report key: 3812436 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-01973
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) FOR THE REPORTED EVENT OF GUIDE CATHETER BROKE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NURSE ENCOUNTERED RESISTANCE WHILE DEPLOYING THE STENT BUT CONTINUED TO TRY AND DEPLOY IT. AS A RESULT, THE INNER CATHETER BROKE AND A PART OF IT WAS DISLODGE IN THE STENT, INSIDE THE PATIENT. THEY WENT BACK IN TO THE PATIENT¿S BILE DUCT AND RETRIEVED THE STENT AND THE BROKEN PART OF THE GUIDE CATHETER USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE 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
    291670 NAVIFLEX? RX DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00533560

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention