BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYSCOPE ACCESS AND DELIVERY CATHETER

    MDR report key: 1542944 · Received November 19, 2009

    Report

    Report Number
    3005099803-2009-05408
    Event Type
    Death
    Date Received
    November 19, 2009
    Date of Event
    October 16, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT 3005099803-2009-05405 AND 3005099803-2009-05407 FOR A DESCRIPTION OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR RX RETRIEVAL BALLOON, A SPYGLASS DIRECT VISUALIZATION PROBE AND A SPYSCOPE ACCESS, AND DELIVERY CATHETER WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WITH SPYGLASS EHL (ELECTROHYDRAULIC LITHOTRIPSY) PROCEDURE PERFORMED IN 2009 (A MALE PT). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STONES WERE BROKEN INTO SMALLER FRAGMENTS USING AN EHL PROBE AND THE SPYGLASS DIRECT VISUALIZATION SYSTEM. THE STONE FRAGMENTS WERE THEN SWEPT OUT WITH AN EXTRACTOR RETRIEVAL BALLOON. THE PHYSICIAN INDICATED THAT HE WAS NOT AWARE OF ANY PT COMPLICATIONS POST PROCEDURE. WHILE AT ANOTHER HOSPITAL, THE PERFORMING PHYSICIAN WAS INFORMED BY A REFERRING PHYSICIAN THAT THE PT HAD EXPIRED. THE EXACT DAY OF THE PT'S DEATH IS UNK; HOWEVER, IT WAS REPORTED TO BE APPROXIMATELY THREE DAYS POST PROCEDURE. AN AUTOPSY WILL NOT BE PERFORMED. THE CAUSE OF DEATH IS UNK AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. 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 AND DELIVERY CATHETER KOG BOSTON SCIENTIFIC CORPORATION M0546230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EHL PROBE