BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 9340512 · Received November 19, 2019

    Report

    Report Number
    3005099803-2019-05570
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE EXPIRATION DATE, 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 DURING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE NEEDLE COILED TOO MUCH WHICH RESULTED IN THE NEEDLE POKING THE MEDIASTINUM AND CAUSING A PNEUMOTHORAX. IT IS UNKNOWN HOW THIS PROCEDURE WAS COMPLETED. DESPITE THE REPORT OF PROLONGED HOSPITALIZATION, THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. 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
    1134833 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552400 08714729986249

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization