BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTHERMX-100 MICROWAVE ABLATION SYSTEM

    MDR report key: 1354272 · Received March 30, 2009

    Report

    Report Number
    1719106-2009-00001
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    March 12, 2009
    Manufacturer
    BSD MEDICAL CORPORATION
    Product Code
    NEY
    PMA / PMN Number
    K081042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT SINCE THE EVENT WAS NOT DEVICE RELATED. PER THE PHYSICIAN, THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A MICROWAVE ABLATION TREATMENT WAS DELIVERED TO A PT DIAGNOSED WITH B-CELL LYMPHOMA IN 1992, WHO CURRENTLY PRESENTED WITH RECURRENT, FOLLICULAR, B-CELL LYMPHOMA WITH METASTASIS TO THE LEFT LOWER LOBE OF THE LUNG. THE PT HAD PREVIOUSLY RECEIVED CHEMOTHERAPY, AND WAS CHEMOTHERAPY RESISTANT, AND MULTIPLE COURSES OF RADIATION THERAPY TO THE MAXIMUM ALLOWED DOSE. THE ABLATION TREATMENT PROCEEDED AS EXPECTED WITH NO DEVICE OR PROCEDURE PROBLEMS. AFTER THE TREATMENT HAD ENDED AND THE PHYSICIAN HAD REMOVED THE APPLICATOR, THE PHYSICIAN OBSERVED BLEEDING FROM THE INTRODUCER CATHETER. THE AREA OF BLEEDING APPEARED TO BE LOCALIZED AT THE PERIPHERY OF THE ABLATION ZONE, APPROX 5 CM FROM THE TIP OF THE ANTENNAE. THE PHYSICIAN PLACED PRESSURE DRESSING. THE PT BECAME HYPOTENSIVE IN THE RECOVERY ROOM; AN X-RAY SHOWED BLOOD IN THE LEFT LUNG. A THORACOTOMY WAS DONE AND 1700 CCS OF BLOOD WAS EXTRACTED FROM THE PLEURAL CAVITY. AFTER THE THORACOTOMY, TWO CHEST TUBES WERE PLACED, WITH MINIMAL DRAINAGE AS THE PT HAD ALREADY STOPPED BLEEDING. THE PHYSICIAN STATED THAT THE MOST LIKELY CAUSE WAS PUNCTURE FROM THE INTRODUCER CATHETER THAT RESULTED IN BLEEDING FROM A FRAGILE VESSEL IN THE TUMOR, PERHAPS AN INTERCOSTAL ARTERY, THAT HAD BEEN PREVIOUSLY DAMAGED FROM THE RADIATION TREATMENTS. AS OF 2009, THE PT WAS HOME AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTHERMX-100 MICROWAVE ABLATION SYSTEM MICROWAVE ABLATION SYSTEM NEY BSD MEDICAL CORPORATION MTX-100 0812-055

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention