BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3240318 · Received July 18, 2013

    Report

    Report Number
    3004962788-2013-00023
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE RETURNED PROCEDURE RECORDING FOR EVALUATION. THE EVALUATION OF THE RECORDINGS FOUND THE SUPERDIMENSION SYSTEM WAS FINE BUT USER INTERFACE WHILE NAVIGATING CONTRIBUTED TO THE EVENT. ADDITIONALLY, THERE WAS A CT TO BODY DIVERGENCE AS THE CT WAS TAKEN IN FULL INHALATION, SO IT IS EXPECTED DURING THE PROCEDURE THE LUNGS WILL BE SHORTER WHICH RESULTED IN REGISTRATION ROTATIONAL ERROR. THE ERROR WAS SUCH THAT THE ANATOMY WAS SUPERIOR TO THE CT AND WHEN THE LOCATABLE GUIDE REACHED THE CT TARGET, IT WAS ACTUALLY MORE INFERIOR TO THE LESION. IT IS ESTIMATED THAT BECAUSE OF THIS WHEN TOOLS WERE INSERTED TO TAKE A BIOPSY THEY WERE GOING TOO INFERIOR CAUSING A PNEUMOTHORAX. A PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR A CT-GUIDED PERCUTANEOUS BIOPSY.

    Description of Event or Problem · 1

    SITE REPORTED A PNEUMOTHORAX IN A PATIENT. THE SUPER DIMENSION CASE WAS COMPLETED ON (B)(6) 2013 AND FLUORO EXAM IN THE OPERATING ROOM AT THE CONCLUSION OF THE CASE DID NOT REVEAL A PNEUMOTHORAX. A CHEST X-RAY SEVERAL HOURS LATER DID REVEAL A PNEUMOTHORAX AND PATIENT WAS ASYMPTOMATIC. REPEAT CHEST X-RAY ABOUT 3 HOURS LATER SHOWED NO CHANGE IN PNEUMOTHORAX AND STILL ASYMPTOMATIC AND PATIENT WAS SENT HOME. TWELVE TO EIGHTEEN HOURS LATER, PATIENT NOTED SOME CHEST PAIN AND WENT TO ANOTHER HOSPITAL WHERE THEY CONCLUDED THE PNEUMOTHORAX WAS INCREASING AND PLACED A PLEURAL CATHETER. THE PATIENT STAYED OVERNIGHT ON (B)(6) 2013, PNEUMOTHORAX RESOLVED AND CATHETER WAS PULLED. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 AND A CHEST X-RAY REVEALED NO PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333325 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization