BEUDAMED
    FDA Adverse Event Death Summary report: N

    JAGWIRE

    MDR report key: 1565662 · Received December 15, 2009

    Report

    Report Number
    3005099803-2009-06128
    Event Type
    Death
    Date Received
    December 15, 2009
    Report Date
    December 3, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (NO ISSUE NOTED). THE COMPLAINANT INDICATED THAT THE DEVICE 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

    NOTE: THE PROCEDURE DATE AND DATE OF DEATH ARE UNKNOWN. NOTE: THIS REPORT PERTAINS TO ONE OF SIX COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2009-06125, 3005099803-2009-06126, 3005099803-2009-06127, 3005099803-2009-06129 AND 3005099803-2009-06130 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED BILIARY STENT, ENCORE SYRINGE, JAGWIRE, AUTOTOME, PLASTIC STENT, AND SNARE WERE ALL USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH AN OCCLUDED PLASTIC PANCREATIC STENT THAT HAD BEEN PLACED TO TREAT CHRONIC PANCREATITIS. THE PHYSICIAN REMOVED THE PLASTIC STENT WITH A SNARE. THE PANCREATIC DUCT WAS THEN CANNULATED WITH AN AUTOTOME AND A GUIDEWIRE WAS INSERTED. A PANCREATOGRAM WAS PERFORMED THAT SHOWED A NON-MALIGNANT DISTAL STRICTURE WITH A 10MM DILATED MAIN DUCT. THE STRICTURE WAS DILATED WITH A COOK TITAN DILATION BALLOON. A 10X6 FULLY COVERED WALLFLEX BILIARY STENT WAS THEN IMPLANTED WITH NO COMPLICATIONS. APPROXIMATELY 36 HOURS LATER, THE WALLFLEX STENT WAS REMOVED BY THE PHYSICIAN WITHOUT ISSUE. THREE TO FOUR DAYS AFTER THE INITIAL ERCP PROCEDURE, THE PATIENT DIED IN THE ICU. THE PATIENT'S CAUSE OF DEATH WAS DETERMINED TO BE E. COLI/SEPSIS. THERE WAS E. COLI IN THE PATIENT'S BLOOD. THE PATIENT HAD A HISTORY OF BACTEREMIA WITH E. COLI. ON CT IMAGING, MILD PANCREATIC INFLAMMATION WAS NOTED WITH FLUID IN ABDOMEN ON THE DATE OF DEATH. NO FREE AIR WAS NOTED WITH NO SIGN OF PERFORATION, AN AUTOPSY WAS NOT PERFORMED. THE PROCEDURE WENT WELL AND WAS COMPLETED WITH THESE DEVICES ACCORDING TO PLAN. THE PHYSICIAN STATED THAT NOTHING ABNORMAL WAS NOTED DURING THE CASE AND ALL PRODUCTS PERFORMED AS PLANNED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE HAD LIMITED SUCCESS. IT SHOULD BE NOTED THAT BSC HAS BEEN UNABLE TO CONFIRM IF ALL THESE PRODUCTS ARE BSC PRODUCTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ENCORE SYRINGE| WALLFLEX FULLY COVERED BILIARY STENT| AUTOTOME| PLASTIC STENT| SNARE