BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 16577408 · Received March 20, 2023

    Report

    Report Number
    3004962788-2023-00034
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    December 12, 2022
    Report Date
    March 20, 2023
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: WHEN PULMONOLOGISTS ARE NOVICE TO NAVIGATIONAL BRONCHOSCOPY, WHAT PREDICTS DIAGNOSTIC YIELD? SOURCE: DIAGNOSTICS 2022, 12, 3127. HTTPS://DOI.ORG/10.3390/DIAGNOSTICS12123127 ACCEPTED: 7 DECEMBER 2022. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNK NEEDLE UNKNOWN BIOPSY NEEDLE, (LOT#UNKNOWN). PRODUCT ID: UNK BRUSH, UNKNOWN CYTOLOGY BRUSH, (LOT#UNKNOWN). PNEUMOTHORAX IS A KNOWN SHORT-TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE STUDY, A PROSPECTIVE STUDY EVALUATED DIAGNOSTIC YIELD IN PATIENTS WHO UNDERWENT ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY PROCEDURES BETWEEN MAY 2018 AND FEBRUARY 2020. ALL PROCEDURES WERE PERFORMED USING THE SUPERDIMENSION NAVIGATION SYSTEM 7.1. 215 PROCEDURES WERE PERFORMED WITH FORCEPS USED IN 190 PATIENTS, NEEDLE USED IN 42 PATIENTS AND CYTOBRUSHES USED IN 120 PATIENTS. COMPLICATIONS INCLUDED: PNEUMOTHORAX AND BRONCHOPULMONARY HEMORRHAGE. CHEST TUBE INSERTION WAS REQUIRED TO TREAT PNEUMOTHORAX IN TWO CASES AND BRONCHOPULMONARY HEMORRHAGE REQUIRED A BALLOON CATHETER IN ONE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17778 SUPERDIMENSION INREACH SYSTEM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-21

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention