BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIFUNCTIONAL LINEAR PEN

    MDR report key: 16480609 · Received March 3, 2023

    Report

    Report Number
    3011706110-2023-00010
    Event Type
    Death
    Date Received
    March 3, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 3, 2023
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K192125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE MLP1 DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER WAS NOT REPORTED. THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT UNDERWENT AN OFF-PUMP, HEPARINIZED VIDEO ASSISTED THORACOSCOPIC (VATS) MAZE PROCEDURE WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION (LAAE). THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE WAS NOT RETRACTED DURING THE ABLATION. 3-4 WEEKS POST-OP, THE PATIENT COLLAPSED AND WAS TRANSPORTED TO THE EMERGENCY ROOM. A CT CONFIRMED AN AIR EMBOLIC STROKE. PATIENT UNDERWENT HYPERBARIC TREATMENT, BUT NEUROLOGICAL SIGNS DID NOT IMPROVE. THE PATIENT WAS TAKEN TO SURGERY, DURING WHICH THE PHYSICIAN OBSERVED A HOLE IN THE ANTERIOR ESOPHAGUS WITH COMMUNICATION BETWEEN THE ANTERIOR ESOPHAGUS AND THE PERICARDIUM. THE HOLE WAS REPAIRED, AND THE PATIENT RETURNED TO THE ICU. POSTOPERATIVELY, THE PATIENT DID NOT RECOVER FROM HIS STROKE AND ULTIMATELY EXPIRED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THIS EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732080 MULTIFUNCTIONAL LINEAR PEN MULTIFUNCTIONAL LINEAR PEN OCL ATRICURE, INC. MLP1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death EMR2, EML2, PRO235.