BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMISITE

    MDR report key: 12278339 · Received August 4, 2021

    Report

    Report Number
    3004962788-2021-00067
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 15, 2021
    Report Date
    February 4, 2022
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521723825
    PMA / PMN Number
    K191394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE LG (LOCATABLE GUIDE) DEVICE HAD NO PHYSICAL DAMAGE OR PHYSICAL DEFECTS; HOWEVER, THE INSPECTION REVEALED THAT THE SEWC HAD KINK/DAMAGE. AFTER FURTHER VISUAL INSPECTION IT REVEALED A SECONDARY KINK/DAMAGE UNDER THE TELESCOPE. THE VISUAL INSPECTION ALSO REVEALED BLOOD CONTAMINATION ON THE LG DEVICE. THE EVALUATION FOUND THAT THE LG (LOCATABLE GUIDE) AND THE SEWC MET LENGTH SPECIFICATIONS. IT WAS REPORTED THAT THE PATIENT PROCEDURE WAS CANCELLED OR ABORTED DUE TO A SYSTEM ISSUE, AND SYSTEM DISPLAYS ERROR MESSAGE INDICATING LG OR PST IS OUTSIDE THE MAGNETIC VOLUME. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT THE LOCATABLE GUIDE DECOUPLED FROM EWC. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE'S LG DETECTED OUTSIDE OF SENSING VOLUME. IN ADDITION, MAGNETIC INTERFERENCE FROM TOOL MESSAGE DISPLAYED ON SCREEN WHEN EWC AND LG STILL COUPLED. ALSO, ON SCREEN CONTINUOUS GUIDANCE INDICATOR (CATHETER TIP) TURNED BLUE WHICH INDICATES THAT LG AND EWC ARE DECOUPLED. THEY WERE COUPLED TOGETHER THE ENTIRE TIME AND SHOULD HAVE BEEN REPRESENTED BY THE MULTICOLOR CATHETER. PHYSICIAN WAS SEEKING FINAL ALIGNMENT TO TARGET BEFORE SAMPLING WITH LG AND EWC STILL COUPLED. THE PHYSICIAN STRUGGLED TO GET IDEAL ALIGNMENT DUE TO APICAL RIGHT UPPER LOBE LESION LOCATION AND LUNG MOVEMENT. WHILE THE PHYSICIAN WAS TWEAKING ALIGNMENT, MAGNETIC INTERFERENCE FROM TOOL DISPLAYED ON SCREEN. THIS WAS WHILE LG AND EWC WERE STILL COUPLED. C-ARM WAS MOVED AWAY FROM PATIENT TO ENSURE THIS WAS NOT THE CAUSE OF THE INTERFERENCE AND FIELD WAS CHECKED FOR OTHER POSSIBLE SOURCES OF INTERFERENCE. THEN NAVIGATION CATHETER IS OUT OF SENSING VOLUME APPEARED ON SCREEN AND DISTANCE TO TARGET SHOWED OVER 25 CM BUT NAV CATH HAD NOT BEEN MOVED. CONTINUOUS GUIDANCE SHOWED THE CATHETER TO BE VIRTUALLY AT THE TARGET BUT DISTANCE TO TARGET SHOWED 25-30 CM AT VARYING TIMES. THE SCREEN DISPLAYED BOTH OF THESE ERROR MESSAGES FOR SEVERAL MINUTES WHILE I ATTEMPTED TO GET HELP TROUBLESHOOTING. GIVEN THE COMPLEXITY OF THE LESION LOCATION AND THE ERRORS, THE PHYSICIAN MADE THE DECISION TO END THE PROCEDURE. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ENB PORTION OF THE CASE AND WAS NOT COMPLETED BY OTHER MEANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173078 ILLUMISITE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC ILS-0900-KT 518369 10884521723825

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other