BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE ACCESS AND DELIVERY CATHETER

    MDR report key: 1162196 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04596
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 3005099803-2008-04597. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE SPYSCOPE WAS DIFFICULT TO STEER. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A SPYSCOPE CATHETER WAS ADVANCED, BUT WAS "EXTREMELY DIFFICULT TO STEER". THE SPYSCOPE CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME DEVICE. AN EXTRACTOR RX 9-12 MM RETRIEVAL BALLOON HAD BEEN ADVANCED INTO THE PATIENT BUT "POPPED" DURING STONE EXTRACTION. THE DEVICE WAS REMOVED INTACT. THE BALLOON WAS EXCHANGED FOR ANOTHER EXTRACTOR RX 9-12 MM. A SPYGLASS DIRECT VISUALIZATION PROBE WAS ALSO USED. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE VISUALIZATION PROBE "BROKE" DUE TO "THE NUMBER OF TIMES BEING REUSED" BUT THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYSCOPE ACCESS AND DELIVERY CATHETER KOG BOSTON SCIENTIFIC M00546230 0ML7110504

    Patients

    Seq Age Sex Outcome Treatment
    1