BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 12924621 · Received December 3, 2021

    Report

    Report Number
    3005099803-2021-05993
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. PREMARKET / 510(K) #: K163248, K151895. (B)(4). IT WAS REPORTED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL EMDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING A BIOPSY PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT POST PROCEDURE, WHILE HOSPITALIZED, THE PATIENT HAD A SIGNIFICANT MEDIASTINAL HEMATOMA. THE MEDIASTINAL HEMATOMA WAS OBSERVED 4 DAYS AFTER THE BIOPSY PROCEDURE. REPORTEDLY, ANTICOAGULANTS WERE USED AS A TREATMENT FOR THE HEMATOMA. THE PHYSICIAN IS UNSURE IF THERE WAS ANY RELATIONSHIP BETWEEN THE NEEDLE DEVICE AND THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821868 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 0027674524 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention