BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY

    MDR report key: 8749934 · Received July 1, 2019

    Report

    Report Number
    3005099803-2019-03373
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. PREMARKET/510(K) #: K163248 & K151895. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY WAS USED IN THE LYMPH NODES DURING A ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A MEDIASTINAL PNEUMOTHORAX BUT IS UNCERTAIN WHETHER OR NOT IT OCCURRED BEFORE OR AFTER THE PROCEDURE. IT IS UNKNOWN HOW THIS PROCEDURE WAS COMPLETED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541444 EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention