BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIFUNCTIONAL LINEAR PEN

    MDR report key: 3027459 · Received March 29, 2013

    Report

    Report Number
    3003502395-2013-00003
    Event Type
    Death
    Date Received
    March 29, 2013
    Date of Event
    March 29, 2012
    Report Date
    May 1, 2018
    Manufacturer
    ATRICURE INC.
    Product Code
    OCL
    PMA / PMN Number
    K100501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AT FACILITY SINCE INITIAL PROCEDURE WAS UNREMARKABLE AND NO DEVICE FAILURE INDICATED. UNABLE TO DETERMINE DEVICE BATCH NUMBER. ATRICURE WAS INITIALLY NOTIFIED OF THIS EVENT THROUGH THE LOCAL SALES REPRESENTATIVE ON (B)(6) 2012. AT THAT TIME, ATRICURE CONTACTED THE SURGEON WHO INDICATED THAT "THERE WAS NO DEVICE RELATED FAILURE OF ANY OF THE ATRICURE PRODUCTS EMPLOYED" AND THAT ATRICURE'S DEVICES DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. AT THIS POINT THE COMPLAINT WAS CLOSED AND THE EVENT WAS DETERMINED TO BE NOT-REPORTABLE. ON (B)(6) 2013 ATRICURE WAS NOTIFIED THAT A JOURNAL ARTICLE WAS RECENTLY PUBLISHED REGARDING THIS EVENT BY PHYSICIANS AT THE HOSPITAL THAT SAW THE PATIENT POST-OP. THE ARTICLE INDICATES THAT A CHEST CT SHOWED A LA-ESOPHAGEAL (A-E) FISTULA AND CONCLUDES "THE A-E FISTULA IN THIS PATIENT LIKELY RESULTED FROM ESOPHAGEAL THERMAL INJURY DURING LINEAR RADIOFREQUENCY ABLATION ON THE POSTERIOR LA." FURTHER DISCUSSIONS TOOK PLACE BETWEEN ATRICURE AND THE ORIGINAL SURGEON BETWEEN (B)(6) 2013. HE HAS INDICATED THAT THIS EVENT WAS ADJUDICATED AT THE INITIAL INSTITUTION AND DETERMINED THAT THE INJURY COULD NOT HAVE COME FROM AN ATRICURE DEVICE, AND THAT THE PATIENT AUTOPSY REVEALED AN ESOPHAGEAL DIVERTICULUM. ATRICURE AGREES WITH THE DETERMINATION MADE BY THE INITIAL SURGEON AND INSTITUTION THAT ATRICURE DEVICES DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. DEVICE DISCARDED BY USER.

    Additional Manufacturer Narrative · 1

    A CORRECTION IS BEING MADE TO UPDATE SECTION D - SUSPECT MEDICAL DEVICE COMPLAINTS LISTED, (B)(4) (3003502395-2013-00003) AND (B)(4) (3003502395-2016-00067) ARE ALL LINKED TO THE SAME COMPLAINT NUMBER (B)(4) , REFERENCES A PROCEDURE DONE BY DR. (B)(6).

    Description of Event or Problem · 1

    ATRICURE WAS NOTIFIED OF A PATIENT DEATH FOLLOWING AN OFF-PUMP, BILATERAL MINI-THORACOTOMY MAZE PROCEDURE USING ATRICURE'S RF ABLATION DEVICES. THE PROCEDURE WAS UNREMARKABLE; HOWEVER, THE PATIENT PRESENTED 3 WEEKS POST-OP AT A DIFFERENT HOSPITAL AND A HEAD CT REVEALED A CEREBRAL PNEUMOCEPHALUS WITH AIR IN THE RIGHT FRONTAL LOBE. THE PATIENT SUBSEQUENTLY EXPIRED. UPON AUTOPSY IT WAS DETERMINED THAT THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA WHICH WAS CONCLUDED TO BE CAUSED BY THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) USED DURING THE SURGICAL PROCEDURE. THE PATIENT AUTOPSY ALSO REVEALED AN ESOPHAGEAL DIVERTICULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130318 MULTIFUNCTIONAL LINEAR PEN MULTIFUNCTIONAL LINEAR PEN OCL ATRICURE INC. MLP1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death