BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1522763 · Received November 5, 2009

    Report

    Report Number
    3004659744-2009-00032
    Event Type
    Death
    Date Received
    November 5, 2009
    Date of Event
    October 8, 2009
    Report Date
    November 5, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY, OR CT-GUIDED PERCUTANEOUS BIOPSY WITH COMPLICATION RATES UP TO APPROXIMATELY 27% WITH THE CT GUIDED PROCEDURE. BIOPSY TOOLS ARE DESIGNED TO HAVE SHARP EDGES AND THEIR FUNCTION IS TO PUNCTURE OR OTHERWISE PENETRATE THE TISSUE IN ORDER TO COLLECT A SPECIMEN.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED A SD BRONCHOSCOPY CASE ON A PT THAT RESULTED IN THE PT EXPIRING DUE TO EXCESSIVE BLOOD LOSS. THIS PT HAD PREVIOUSLY HAD A RIGHT LOWER LOBE THORACOTOMY SURGERY AND A MEDIASTINAL LYMPH NODE RESECTION PERFORMED IN 2009, AS A RESULT OF THE SUPERDIMENSION DIAGNOSIS. HOWEVER, SEVEN MONTHS LATER, IT WAS FOUND FROM A CT SCAN THAT THERE WERE MULTIPLE NEW LESIONS DISCOVERED IN THE PT'S LUNGS. DURING THE CASE THE FOLLOWING MONTH, THE PHYSICIAN STARTED TO NAVIGATE INTO THE APICAL AIRWAY OF THE LEFT UPPER LOBE WHEN HE NOTICED SOME BLEEDING THAT STARTED. SHORTLY AFTER, THE BLEEDING STARTED TO PERSIST UNTIL IT BECAME OVERWHELMING. THE DOCTOR AND HIS HOSPITAL STAFF WORKED ON THE PT FOR APPROXIMATELY 45 MINUTES UNTIL SHE WAS PRONOUNCED DEAD DUE TO BLOOD LOSS. THE PHYSICIAN DOES NOT THINK THAT ANY OF THE BLEEDING WAS RELATED TO THE SD PROCEDURE. HE DID NOT TAKE A BIOPSY SAMPLE OR EVEN INSERT A BIOPSY TOOL PRIOR TO THE BLEEDING. THERE WAS NO ALLEGATION THAT THE SUPERDIMENSION SYSTEM CAUSED THE REPORTED PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death