BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION

    MDR report key: 16924225 · Received May 12, 2023

    Report

    Report Number
    3004962788-2023-00048
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    October 8, 2022
    Report Date
    May 12, 2023
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K151376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: AAS00161-20 US SUPERD NAVIGATION SYSTEM (SERIAL#: UNKNOWN) TITLE: NOVEL IMAGE-GUIDED FLEXIBLE-PROBE TRANSBRONCHIAL MICROWAVE ABLATION FOR STAGE 1 LUNG CANCER SOURCE: RESPIRATION 2023;102:182¿193 PUBLISHED DATE: JANUARY 18, 2023. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY AND FEASIBILITY OF IMAGE-GUIDED TRANSBRONCHIAL MICROWAVE ABLATION FOR PATIENTS WITH PERIPHERAL STAGE 1 LUNG CANCER. THE ABLATION PROCEDURE WAS PERFORMED USING NAVIGATIONAL BRONCHOSCOPY AND A FLEXIBLE MICROWAVE ABLATION PROBE WHICH WAS GUIDED BY COMPUTED TOMOGRAPHY AND FLUOROSCOPY. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY WAS PERFORMED WITH SUPERDIMENSION 7.1. EDGE WAS USED WITHOUT NAVIGATION IN TWO PATIENTS WHERE THERE WERE TECHNICAL DIFFICULTIES WITH SUPERDIMENSION. THERE WERE TEN PATIENTS IN THE STUDY AND MILD COMPLICATIONS INCLUDED: SCANT HEMOPTYSIS, CHEST WALL PAIN, COUGH, AND DYSPNEA. ONE PATIENT EXPERIENCED HEMORRHAGE WHICH WAS TREATED INTRAOPERATIVELY WITH COLD SALINE AND BRONCHOSCOPIC TAMPONADE. ONE PATIENT ALSO HAD LENGTHY BRONCHOSCOPIC NAVIGATION WITH LOCAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309251 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention