BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 14679622 · Received June 13, 2022

    Report

    Report Number
    3005099803-2022-03082
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: K163248 AND K151895. (B)(4). THE COMPLAINANT INDICATED 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 AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FIRST EXIT OF THE SHEATH FROM THE TIP OF THE DEVICE WAS SLIGHTLY DIFFICULT BUT THE NEEDLE REACHED THE LUMP TO BE PUNCTURED. THE OPERATOR RE-INTRODUCED THE DEVICE INTO THE ENDOSCOPE CHANNEL, BUT THE SHEATH DID NOT SLIDE FORWARD. THE NEEDLE HANDPIECE WAS BLOCKED AND DID NOT ALLOW ANY MOVEMENT OF EITHER THE SHEATH OR THE NEEDLE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AS A SECOND NEEDLE DEVICE WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180688 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 0028753073 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown