BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE ACCESS AND DELIVERY CATHETER

    MDR report key: 1192096 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05080
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CORP IN 2008, THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER WAS PLANNED FOR USE DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED THREE DAYS LATER. ACCORDING TO THE COMPLAINANT, "THE PULL WIRES FELT LIKE THEY HAD BROKEN AND SNAPPED DURING THE PROCEDURE, PREVENTING THE PHYSICIAN FROM STEERING THE CATHETER. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS UNABLE TO GET AN IMAGE DUE TO THE MALFUNCTION AND TERMINATED THE PROCEDURE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'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 AND DELIVERY CATHETER KOG BOSTON SCIENTIFIC CORPORATION M00546230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other