BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION

    MDR report key: 10922523 · Received November 30, 2020

    Report

    Report Number
    3004962788-2020-00068
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    July 7, 2020
    Report Date
    November 30, 2020
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMAGE-GUIDED ABLATIVE THERAPIES FOR LUNG TUMORS SOURCE: LUNG CANCER-MODERN MULTIDISCIPLINARY MANAGEMENT, DOI: HTTP://DX.DOI.ORG/10.5772/INTECHOPEN.94216 PAGES 1-23 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 LITERATURE SOURCE OF STUDY PERFORMED SINCE EARLY 2019, 45 PATIENTS HAVE UNDERGONE ENDOLUMINAL ABLATION WITH THE ABLATION CATHETER GUIDED BY THE SUPERDIMENSION NAVIGATION SYSTEM. TWO PATIENTS (4.4%) DEVELOPED A PNEUMOTHORAX REQUIRING CHEST TUBE DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386481 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-20C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other