BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYSCOPE ACCESS & DELIVERY CATHETER

    MDR report key: 1558634 · Received December 9, 2009

    Report

    Report Number
    3005099803-2009-05925
    Event Type
    Death
    Date Received
    December 9, 2009
    Date of Event
    November 24, 2009
    Report Date
    November 25, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2009-05924 AND 3005099803-2009-05926 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX STENT, DREAMWIRE, AND A SPYSCOPE ACCESS AND DELIVERY CATHETER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CHOLANGIOSCOPY WITH METAL STENT PLACEMENT PERFORMED IN 2009. ACCORDING TO THE COMPLAINT, FOUR DAYS POST PROCEDURE, THE PATIENT EXPIRED DUE TO SEPSIS. PRIOR TO THE PROCEDURE, THE PATIENT HAD METASTATIC DISEASE FROM CHOLANGIOCARCINOMA. THE PATIENT WAS REPORTED TO BE VERY SICK GOING INTO THE PROCEDURE. THE DOCTOR'S ASSESSMENT OF THIS EVENT WAS THAT THE PATIENT'S DEATH WAS NOT DEVICE RELATED, BUT WAS UNABLE TO STATE THIS ABSOLUTELY. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE. BOSTON SCIENTIFIC CONFIRMED THAT A PERFORATION DID NOT OCCUR DURING THE PROCEDURE. NO ISSUES WITH ANY BOSTON SCIENTIFIC DEVICES WERE REPORTED DURING OR POST PROCEDURE. POST-PROCEDURE, THE PATIENT REMAINED VERY SICK. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE HAD LIMITED SUCCESS. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYSCOPE ACCESS & DELIVERY CATHETER KOG BOSTON SCIENTIFIC CORPORATION M00546230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death DREAMWIRE WALLFLEX BILIARY RX STENT