BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE ACCESS & DELIVERY CATHETER

    MDR report key: 1260087 · Received December 10, 2008

    Report

    Report Number
    3005099803-2008-07055
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON FIVE DAYS EARLIER (A FEMALE PATIENT; WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT COMPLAINED OF RIGHT ABDOMINAL PAIN. A CT SCAN WAS PERFORMED AND A PERFORATION WAS DISCOVERED IN THE CYSTIC DUCT; THE PHYSICIAN THOUGHT THE PERFORATION MAY HAVE BEEN CAUSED DURING THE ERCP PROCEDURE DUE TO PRESSURE FROM THE IRRIGATION PROCESS. IT WAS ALSO NOTICED THAT THE PATIENT'S GALLBLADDER WAS "FULL OF STONES"; THE GALLBLADDER WAS REMOVED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    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 39 YR Other