BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE SYNERGY ABLATION SYSTEM

    MDR report key: 6290301 · Received January 31, 2017

    Report

    Report Number
    3003502395-2017-00020
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 4, 2017
    Manufacturer
    ATRICURE INC.
    Product Code
    OCM
    PMA / PMN Number
    P100046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0305.C. THE DEVICE MET ALL CRITERIA AND FUNCTIONED NORMALLY. THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    MITRAL VALVE REPAIR/REPLACEMENT-MAZE-POSSIBLY TRICUSPID VALVE REPAIR OPEN STERNOTOMY. DURING THE MAZE PROCEDURE, THE SURGEON ABLATED THE LEFT PULMONARY VEINS 6 TIMES. THEN, USING THEIR OWN PACING FORCEPS, TESTED FOR ISOLATION, IT WAS NOTED VEINS WERE NOT ISOLATED. HE THEN ABLATED 6 MORE TIMES AND AGAIN WAS UNABLE TO GAIN ISOLATION OF THE LEFT PULMONARY VEINS. AT THIS TIME, WHEN THE SURGEON LIFTED UP THE LEFT SIDE OF THE HEART TO LOOK AT THE LEFT PULMONARY VEINS, HE NOTICED A HOLE AT ONE OF HIS ABLATION LINES ON THE PV. AT THIS TIME HE ARRESTED THE HEART AND COMPLETED THE MAZE PROCEDURE. AFTER COMPLETING THE EXCLUSION OF THE LEFT ATRIAL APPENDAGE AND THE CONNECTING LESION TO THE SUPERIOR LEFT PULMONARY VEIN, HE THEN ABLATED THE LEFT PULMONARY VEINS 2 MORE TIMES. AFTER COMPLETING THE MAZE HE THEN REPAIRED THE HOLE IN THE LEFT PULMONARY VEINS AT THE ABLATION LINE. SURGEON'S COMPLAINT WAS THAT HE FELT THAT THE CLAMP OR ALGORITHM OF THE ASU WAS NOT WORKING RIGHT. THE SAME CLAMP WAS USED FOR THE ENTIRE CASE AND GOOD LESIONS WERE ACHIEVED ON ALL OTHER PARTS OF THE MAZE PROCEDURE. OVER ABLATING THE LEFT PULMONARY VEINS COULD HAVE DAMAGED TISSUE AND CAUSED THE HOLE IN THE ABLATION LINE. PATIENT WAS ON PUMP AND HEPARINIZED. THE CASE WAS DELAYED BY TEN TO FIFTEEN MINUTES. SURGEON COMPLETED MAZE, REPAIRED HOLE IN LEFT PULMONARY VEIN, COMPLETED MVR AND TVR. CLAMP WAS CLEANED AFTER EVERY 6TH ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74172 ATRICURE SYNERGY ABLATION SYSTEM ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW OCM ATRICURE INC. OLL2 69612

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R