BEUDAMED
    FDA Adverse Event Death Summary report: N

    "ISOLATOR SYNERGY"" ENCOMPASS CLAMP AND GUIDE "

    MDR report key: 14218670 · Received April 27, 2022

    Report

    Report Number
    3011706110-2022-00012
    Event Type
    Death
    Date Received
    April 27, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 27, 2022
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    UDI-DI
    10840143904110
    PMA / PMN Number
    K210477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT, THE OLH CLAMP, LOT NUMBER 116767, WAS VISUALLY AND FUNCTIONALLY INSPECTED PURSUANT TO SPECIFIC ATRICURE INVESTIGATION PROCEDURES. DEVICE MET ALL SPECIFICATIONS AND PASSED RETURN EVALUATION CHECKLIST. UNABLE TO CONFIRM ANY NON-CONFORMITIES.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, HYPERTENSION, DIABETES, AND KIDNEY DISEASE UNDERWENT A 3-VESSEL CORONARY ARTERY BYPASS GRAFT (CABG) SURGICAL PROCEDURE WITH CONCOMITANT RF ABLATION. AFTER ROUTING THE ENCOMPASS CLAMP, THE PHYSICIAN LIFTED THE HEART TO VISUALIZE THE CLAMP JAW LOCATION BUT COULD NOT VISUALIZE THE LOWER CLAMP JAW. FURTHER INSPECTION REVEALED AN INJURY TO THE RIGHT INFERIOR PULMONARY VEIN WHICH WAS REPAIRED WITH 2-PLEDGETED SUTURES. THAT NIGHT, THE PATIENT SHOWED SIGNS AND SYMPTOMS OF A STROKE. CT TESTING CONFIRMED AN EMBOLIC STROKE AND PATIENT ULTIMATELY EXPIRED ON (B)(6) 2022. THERE IS NO CONFIRMED CAUSAL LINK BETWEEN THE RF ABLATION AND THE STROKE. CONTRIBUTION FROM THE RF ABLATION PROCEDURE CANNOT BE RULED OUT, SO THIS EVENT IS BEING REPORTED PER PART 803. THIS WAS A PROCEDURAL COMPLICATION AND THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792686 "ISOLATOR SYNERGY"" ENCOMPASS CLAMP AND GUIDE " "ISOLATOR SYNERGY"" ENCOMPASS CLAMP AND GUIDE " OCL ATRICURE, INC. OLH 116767 10840143904110

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death