BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 12340300 · Received August 18, 2021

    Report

    Report Number
    3004962788-2021-00069
    Event Type
    Injury
    Date Received
    August 18, 2021
    Report Date
    August 18, 2021
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MANAGEMENT OF BRONCHOPLEURAL FISTULA WITH ENDOBRONCHIAL VALVE IN HYBRID OPERATING ROOM FOLLOWING TRANSBRONCHIAL MICROWAVE ABLATION. SOURCE: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY (2021) 1¿3 DOI:10.1093/ICVTS/IVAB183 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, POSTOPERATIVE CHEST X-RAY SHOWED RIGHT PNEUMOTHORAX AND A CHEST DRAIN WAS INSERTED. WHILE WAITING FOR CT SCAN, TALC PLEURODESIS WAS PERFORMED FOR MODERATE PERSISTENT AIR LEAK ON POST-ABLATION DAY 9, BUT TO NO AVAIL. CT SCAN ON POST-ABLATION DAY 13 SHOWED RESIDUAL PNEUMOTHORAX AND A BRONCHOPLEURAL FISTULA THROUGH ABLATED LUNG. THEY YECIDED FOR ENDOBRONCHIAL VALVE IMPLANTATION ON POST-ABLATION DAY 18 IN VIEW OF PERSISTENT AIR LEAK. INTRAOPERATIVELY, BLOCKING OF THE RML LATERAL SEGMENTAL BRONCHUS WITH A 3-FR EM-BOLECTOMY BALLOON LED TO A DROP IN AIR LEAK ON DIGITAL CHEST DRAIN MONITOR FROM 140 TO 0¿40 ML/MIN. A ZEPHYRRV 4.0 ENDOBRONCHIAL VALVE (PULMONX CORP., REDWOOD CITY, CA, USA) WAS INSERTED TO RML LATERAL SEGMENTAL BRONCHUS WITH GOOD FIT. NO AIR LEAK WAS NOTED THEREAFTER, CHEST DRAIN WAS REMOVED 2 DAYS LATER AND PATIENT WAS DISCHARGED. THE ENDOBRONCHIAL VALVE WAS REMOVED WITH BRONCHOSCOPE 6 WEEKS AFTER IMPLANTATION. CT SCAN AFTER REMOVAL SHOWED A HEALED FISTULA TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232402 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention