BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH SYS

    MDR report key: 4092456 · Received September 4, 2014

    Report

    Report Number
    3004962788-2014-00048
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 7, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE SUPERDIMENSION SUPERLOCK NITINOL MARKER CONFIRMED THE MARKER WAS DAMAGED, WHICH IMPACTED THE ABILITY TO EJECT. THE CAUSE OF THE DAMAGE IS UNDETERMINED. IT IS UNDETERMINED IF THE DAMAGED MARKER CONTRIBUTED TO THE PNEUMOTHORAX. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY.

    Description of Event or Problem · 1

    THE PT SUFFERED A PNEUMOTHORAX DURING A SUPERDIMENSION PROCEDURE. THE FIDUCIAL MARKER GOT STUCK. THE PHYSICIAN TRIED TO PUSH THE MARKER THROUGH BY PUSHING ON THE SCOPE. THE PHYSICIAN BELIEVES IT MAY HAVE CONTRIBUTED TO THE PNEUMOTHORAX. THE PT REQUIRED A CHEST TUBE FOR FOURTEEN HOURS AFTER THE CASE AND WAS THEN DISCHARGED. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541667 SUPERDIMENSION INREACH SYS ELECTROMAGNETIC NAVIGATION BRONCHOS JAK SUPERDIMENSION INC. AAS00161-12C

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R SUPERDIMENSION MARKER DELIVERY KIT SDMDK1000| SUPERLOCK NITINOL AND GOLD MARKER, SDGN447