BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREDX

    MDR report key: 18169909 · Received November 20, 2023

    Report

    Report Number
    3005099803-2023-06180
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    October 26, 2023
    Report Date
    November 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729971054
    PMA / PMN Number
    K183085
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H10: IMDRF DEVICE CODE A0401 AND IMPACT CODE E2301 CAPTURES THE REPORTABLE EVENT OF ONE SIDE OF THE FORCEPS BROKE OFF IN THE PATIENT LUNG MASS AND WAS UNRETRIEVED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, ONE SIDE OF THE FORCEPS DETACHED INTO THE PATIENT'S LUNG MASS AND WAS NOT RETRIEVED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797165 COREDX BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00515220 0032120246 08714729971054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention