BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROWAVE ANTENNA LT

    MDR report key: 6183689 · Received December 16, 2016

    Report

    Report Number
    1719106-2016-00001
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 13, 2016
    Manufacturer
    PERSEON CORPORATION
    Product Code
    NEY
    PMA / PMN Number
    K141785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATMENT PROCEEDED NORMALLY, AND THERE WERE NO KNOWN EQUIPMENT MALFUNCTIONS. THE DEVICE HISTORY SHOWED THAT THE ANTENNA LOT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 0

    THE PHYSICIAN COMPLETED A MICROWAVE ABLATION TREATMENT OF A 6 CM RENAL MASS USING 3 ANTENNAS. THE MASS HAD GROWN RAPIDLY FROM 2.5 TO 6 CM PRIOR TO TREATMENT. FOLLOWING THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE RAPIDLY DETERIORATED. THE ANTENNAS WERE WITHDRAWN AND ADDITIONAL CT IMAGING PERFORMED. SIGNIFICANT BLEEDING FROM THE AREA OF THE ABLATION WAS NOTED. ENDOVASCULAR INTERVENTION WAS PERFORMED TWICE TO STABILIZE THE PATIENT'S VITAL SIGNS. THE PATIENT WAS STABILIZED AND RETURNED TO ICU. THE PATIENT HAD A LONG HISTORY OF CORONARY ARTERY DISEASE AND AN AORTIC STENT. THE PATIENT WAS ON ANTI-COAGULATION THERAPY PRIOR TO THE TREATMENT, WHICH MAY HAVE CAUSED THE RAPID GROWTH OF THE MASS AND THE SUBSEQUENT HEMORRHAGE. THE TREATMENT PROCEEDED NORMALLY, AND THERE WERE NO KNOWN EQUIPMENT MALFUNCTIONS. THE PATIENT SUBSEQUENTLY DIED FORM COMPLICATIONS OF PNEUMONIA IN THE ICU ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834323 SYNCHROWAVE ANTENNA LT SYNCHROWAVE ANTENNA NEY PERSEON CORPORATION SW-1415 U851

    Patients

    Seq Age Sex Outcome Treatment
    0 80 YR Hospitalization| L| R