BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION

    MDR report key: 730309 · Received June 19, 2006

    Report

    Report Number
    2939222-2006-00013
    Event Type
    Other
    Date Received
    June 19, 2006
    Date of Event
    April 6, 2006
    Report Date
    June 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC EP TECHNOLOGIES
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: METHOD - PRODUCT INVOLVED IN COMPLAINT WAS TESTED AND VISUALLY INSPECTED. PHOTOS WERE TAKEN DURING EVALUATION. SEE PAGE 3 FOR PICTURE OF CHAR. ALSO, THE DFU OF THE CONSTELLATION WAS ALSO REVIEWED FOR ADEQUACY. RESULT - THE CONSTELLATION HAS NO MEANS TO PRODUCE THE ENERGY REQUIRE FOR CHARRING TO OCCUR. THEREFORE, THE CHAR ON THE CONSTELLATION WAS CAUSED BY THE OTHER DEVICE. REVIEW FOUND THE DFU PROVIDED ADEQUATE WARNING ON THE USE OF THE CONSTELLATION IN CONJUNCTION WITH RF ABLATION CATHETER. OBSERVATION ON THE DEVICE INDICATES THE USER USED INCORRECT TECHNIQUES, AND FAILED TO FOLLOW DFJ INSTRUCTION. CONCLUSION - THERE IS NO DEVICE FAILURE. USER ERROR HAS CAUSED THE CHARRING ON THE CONSTELLATION.

    Description of Event or Problem · 1

    "AT END OF PROCEDURE (ABLATION OF RIGHT ATRIUM) WHEN REMOVING THE CATHETER, THE CATHETER WAS BADLY CHARRED." THERE WAS NO ADVERSE EVENT, AND THE INVESTIGATION OF THE RETURNED DEVICE FOUND NO DEVICE MALFUNCTION. HOWEVER, DUE TO THE RISK OF SERIOUS INJURY THAT CAN RESULT FROM USER NOT FOLLOWING INSTRUCTION ON PRODUCT DFU, IT IS DECIDED THAT FILING A MDR TO THE FDA WOULD BE AN APPROPRIATE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION RECORDING AND PACING CATHETER MTD BOSTON SCIENTIFIC EP TECHNOLOGIES M004US8031U0 8119749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BLAZER XP 8MM ABLATION CATHETER,| EPT XP GENERATOR AND ESI MAPPING SYSTEM