BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2250212 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03131
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-03131 AND MANUFACTURER REPORT # 3005099803-2011-03132 ADDRESS THE TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO ADVANIX BILIARY STENTS WITH NAVIFLEX RX DELIVERY SYSTEMS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON A FEMALE PATIENT ON (B)(6), 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE STENTS WERE ATTEMPTED TO BE PLACED WITHIN A STRICTURE OF THE HEPATIC DUCT TO FACILITATE BILE DRAINAGE. DURING THE PROCEDURE, WHEN ADVANCING THE STENTS INSIDE THE PATIENT, THE CATHETER INTRODUCERS WOULD NOT FOLLOW THE GUIDEWIRE AROUND AN ACUTE ANGLE; AS A RESULT, THE STENTS COULD NOT BE PLACED. IT WAS THOUGHT THAT THE AVAILABLE EQUIPMENT WOULD PRESENT THE SAME ISSUE.; THEREFORE THE PROCEDURE WAS NOT COMPLETED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTED TO EITHER DEVICE. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AT THE TIME OF THIS PROCEDURE, HOWEVER THE PROCEDURE WAS RESCHEDULED FOR LATER ON IN THE WEEK OF (B)(6), 2011. 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 STABLE AND IT WAS ALSO CONFIRMED THE PATIENT IS OKAY IN HER CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00533580

    Patients

    Seq Age Sex Outcome Treatment
    1 JAGWIRE (BSC)