BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION

    MDR report key: 7906805 · Received September 25, 2018

    Report

    Report Number
    3004962788-2018-00050
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 17, 2018
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K173244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CT SCAN SHOWED UNUSUAL ANATOMY WERE THE PATIENT WAS MISSING THE RIGHT LUNG. THIS CAUSED THE TREE CONSTRUCTING ALGORITHM TO CONSIDER THE LEFT BRONCHUS A PART OF THE TRACHEA AND CREATE THE FIRST SPLIT INSIDE THE LEFT LUNG. ACCORDING TO AUTOMATIC REGISTRATION ANALYSIS THE REGISTRATION SAMPLES WERE MATCHED TO THE 3D TREE, HOWEVER, THIS CAN AFFECT REGISTRATIONS QUALITY. ANALYSIS ALSO SHOWED CT-TO-BODY DIVERGENCE IN TARGET LOBE. PROCEDURE RECORDING VIDEO SHOWED FLUOROSCOPIC IMAGE DURING THE FIDUCIAL MARKER PLACEMENT. ACCORDING TO VIDEO ANALYSIS, THE MARKER INSERTION TOOL USED FOR MARKER PLACEMENT WAS SIGNIFICANTLY EXTENDED OUT OF THE CATHETER DURING THE FIRST AND THIRD MARKER PLACEMENTS. THE THIRD MARKER WAS PLACED IN REMOTE POSITION FROM THE CATHETER. THE FIDUCIAL PLACEMENT FEATURE CAN ONLY SUGGEST POSITION IN AREAS THAT WERE ALREADY SURVEYED BY THE PHYSICIAN. ON THE FIRST CAPTURE, THE FIRST ATTEMPT TO TAKE AP IMAGE FAILED DUE TO THE SYSTEMS EVALUATION OF THE C-ARM NOT BEING POSITIONED IN AP (THERE IS A 7 DEGREE TOLERANCE, WHILE THE ANGLES DURING CAPTURE WAS -22.51). THE FLUOROSCOPIC NAVIGATION MODULE FAILED TO COMPLETE DUE TO CATHETER CORRECTION OF 30.82 MM, ABOVE THE 30 MM THRESHOLD. ON THE SECOND CAPTURE, THE FIRST ATTEMPT TO TAKE AP IMAGE FAILED DUE TO THE SYSTEMS EVALUATION OF THE C-ARM NOT BEING POSITIONED IN AP (THERE IS A 7 DEGREE TOLERANCE, WHILE THE ANGLES DURING CAPTURE WAS -28.38). THE FLUOROSCOPIC NAVIGATION MODULE FAILED TO COMPLETE DUE TO CATHETER CORRECTION OF 31.17 MM, ABOVE THE 30 MM THRESHOLD. THE EXCESSIVE CORRECTIONS ARE POSSIBLY DUE TO CT-TO-BODY DIVERGENCE IN THE INITIAL REGISTRATION. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SYSTEM, CASE RECORDINGS ARE EXPECTED TO BE RETURNED BUT HAVE NOT YET BEEN RECEIVED. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS OF THE SUPERDIMENSION CONSOLE INDICATES THIS DEVICE WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. PNEUMOTHORAX IS A KNOWN SHORT-TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX, AND A FIDUCIAL ON THE PLEURA. AUTOMATIC REGISTRATION WAS ABLE TO BE COMPLETED WITH NO ISSUES. THE PHYSICIAN NAVIGATED TO TARGET AND LAUNCHED THE FIDUCIAL. AFTER COMPLETING STEPS AN ERROR MESSAGE DISPLAYED THAT WE WERE NOT ABLE TO COMPLETE THE FLUORONAV PORTION OF THE CASE. THE PHYSICIAN DECIDED TO PLACE FIDUCIALS USING THE FIDUCIAL PLACEMENT FEATURE AND 3 FIDUCIALS WERE PLACED. THE FIDUCIAL WILL HAVE TO BE REMOVED WITH ANOTHER PROCEDURE. A CHEST TUBE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745398 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-20 7.2 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention