BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 11653222 · Received April 12, 2021

    Report

    Report Number
    3005099803-2021-01540
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. PREMARKET / 510(K) #: K163248, K151895. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED, AFTER THE PROCEDURE, THAT THE PATIENT WAS IN CRITICAL CONDITION AND SUFFERED BLEEDING COMPLICATIONS. THERE WAS NO REPORTED DEVICE BREAKAGE AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE BLEED WAS TREATED, HOWEVER, IT IS UNKNOWN HOW IT WAS TREATED. IT IS ALSO UNKNOWN WHAT THE CAUSE OF THE BLEED WAS. THERE IS NO UPDATE ON THE PATIENT'S CURRENT STATUS. 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
    551309 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention