BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENCUT

    MDR report key: 16746942 · Received April 14, 2023

    Report

    Report Number
    3004962788-2023-00041
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 14, 2023
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    EOQ
    UDI-DI
    10884521539716
    PMA / PMN Number
    K142839
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLEEDING IS A KNOWN SHORT-TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: ILS-2100-PN, ARCPOINT PULMONARY NEEDLE, 21 G (LOT#UNKNOWN) TITLE: SAFETY AND FEASIBILITY OF ULTRATHIN PROBE TRANSBRONCHIAL LUNG CRYOBIOPSY (UP-TBLC) WITHOUT BALLOON BLOCKER VIA ROBOTIC BRONCHOSCOPY IN THE EVALUATION OF PERIPHERAL LUNG LESIONS (PPLS): A RETROSPECTIVE PILOT STUDY SOURCE: SAFETY AND FEASIBILITY OF ULTRATHIN PROBE TRANSBRONCHIAL LUNG CRYOBIOPSY (UP-TBLC) WITHOUT BALLOON BLOCKER VIA ROBOTIC BRONCHOSCOPY IN THE EVALUATION OF PERIPHERAL LUNG LESIONS (PPLS): A RETROSPECTIVE PILOT STUDY. ERJ OPEN RES 2023; IN PRESS (HTTPS://DOI.ORG/10.1 183/23120541.00638-2022). 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 SOURCE, THE STUDY WAS ABOUT THE EXPERIENCE OF ULTRATHIN PROBE TRANSBRONCHIAL LUNG CRYOBIOPSY (UP-TBLC) VIA THE MONARCH ROBOTIC-ASSISTED BRONCHOSCOPY (RAB) SYSTEM FOR THE DIAGNOSIS OF PPLS WITH PRIMARY ENDPOINTS OF SAFETY AND FEASIBILITY. THIS WAS A RETROSPECTIVE REVIEW OF 58 LESIONS IN 53 PATIENTS THAT UNDERWENT RAB WITH RADIAL PROBE ENDOBRONCHIAL ULTRASONOGRAPHY (RP-EBUS) GUIDED UP-TBLC, COMPLIMENTING TRADITIONAL SAMPLING METHODS OF PPLS DURING SINGLE USER¿S FIRST ADOPTION OF RAB BETWEEN JUNE 2022 AND NOVEMBER 2022.UNDER GENERAL ANESTHESIA VIA AN ENDOTRACHEAL TUBE, MONARCH, RAB WITH RP-EBUS LESION CONFIRMATION WAS PERFORMED. TISSUE ACQUISITION WAS OBTAINED FOR ALL LESIONS IN THE FOLLOWING SEQUENCE: 21 GAUGE NEEDLE BIOPSY AND 15G BIOPSY CORING TOOL ASPIRATIONS, 1.1 MM UP-TBLC, FORCEPS BIOPSY AND BRONCHOALVEOLAR LAVAGE (BAL). THREE INCIDENTS OF PNEUMOTHORAX (5%) OCCURRED. ALL REQUIRED INTERVENTIONS. ONE WAS DISCHARGED ON THE SAME DAY WITHOUT SMALL BORE CHEST TUBE (SBCT) AFTER SUCCESSFUL MANUAL ASPIRATION, ONE DISCHARGED WITH SBCT FOR AMBULATORY MANAGEMENT AND ONE HOSPITALIZED WITH SBCT AFTER FAILING MANUAL ASPIRATION. BOTH CHEST TUBES WERE REMOVED WITHIN 72 HOURS. FOUR GRADE 2 BLEEDS (6.9%) OCCURRED BASED ON THE NASHVILLE BLEEDING SCALE, MEANING A REQUIREMENT OF ONE OR MORE TOOLS WERE USED TO CONTROL OR PREVENT FURTHER BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827947 GENCUT BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ COVIDIEN LP - SUPERDIMENSION INC SDCT01 10884521539716

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R