BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANIX BILIARY STENT

    MDR report key: 5058080 · Received September 4, 2015

    Report

    Report Number
    3005099803-2015-02562
    Event Type
    Death
    Date Received
    September 4, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE WAS IMPLANTED 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

    THIS REPORT IS ONE OF SIX COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2015-02562, 3005099803-2015-02563, 3005099803-2015-02564, 3005099803-2015-02565, 3005099803-2015-02568, AND 3005099803-2015-02573). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE (3) RX CYTOLOGY BRUSHES, AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM, AND AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PAPILLOTOMY, BRUSHING AND BILIARY STENT PLACEMENT PROCEDURE ON (B)(6) 2015. THE INDICATIONS FOR THIS PROCEDURE WERE FOR "CHEST PAIN, ELEVATED LFT, SUSPECTED CHOLEDOCHOLITHIASIS WITH MARKEDLY DILATED BILE DUCT ON MRCP." ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN AUTOTOME RX SPHINCTEROTOME WAS USED TO PERFORM THE SPHINCTEROTOMY. THE PATIENT'S ANATOMY WAS REPORTED TO BE A DILATED OR LARGER DUCT AFTER THE SPHINCTEROTOMY AND BALLOON (MANUFACTURER UNKNOWN) DILATION. THE OLYMPUS ERCP SCOPE WAS PLACED IN A TORQUE POSITION. WHILE ATTEMPTING TO OBTAIN A SAMPLE FROM A NOTED DISTAL STRICTURE, THE PHYSICIAN WAS TRYING TO MOVE THE RX CYTOLOGY BRUSH IN AND OUT OF THE CATHETER, AND THE WIRE NEAR THE HANDLE BROKE. THIS OCCURRED WITH TWO (2) RX CYTOLOGY BRUSHES. THE BROKEN WIRE WAS AT THE USER END OF THE CATHETER, OUTSIDE THE PATIENT. A THIRD RX CYTOLOGY BRUSH WAS USED TO COMPLETE THAT PORTION OF THE PROCEDURE, AND THERE WERE NO ISSUES WITH THIS DEVICE. AN ADVANIX BILIARY STENT WAS PLACED USING A NAVIFLEX RX DELIVERY SYSTEM. REPORTEDLY, THERE WERE NO ISSUES WITH THE ADVANIX BILIARY STENT, NAVIFLEX RX DELIVERY SYSTEM, AND THE AUTOTOME RX SPHINCTEROTOME AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2015, THE PATIENT'S CULTURE TESTED POSITIVE FOR E. COLI. ON (B)(6) 2015, A NO CONTRAST CT WAS COMPLETED FOR THE PATIENT RESULTING IN "NO ACUTE ABNORMALITY ON NO CONTRAST CT WITH NO EVIDENCE FOR PANCREATITIS, BOWEL OBSTRUCTION OR FREE AIR." THE PATIENT DIED ON (B)(6) 2015 DUE TO E. COLI SEPSIS. THE CAUSE OF THE E. COLI SEPSIS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588136 ADVANIX BILIARY STENT CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER UNK686

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death