BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 15974679 · Received December 13, 2022

    Report

    Report Number
    3005099803-2022-07247
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 14, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). PREMARKET / 510(K) #: K163248 & K151895. IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF RESCHEDULED EXAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE BRONCHUS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE COULD BE PUSHED THROUGH THE DEVICE AND FASTENED WITHOUT ANY PROBLEMS. WHEN IT CAME TO PUNCTURING THE NEEDLE, THE CATHETER COULD NOT BE GUIDED OUT OF THE DEVICE AND THEREFORE NO PUNCTURE COULD TAKE PLACE. THE EXAMINATION WAS TERMINATED, AND THEY ATTEMPTED TO USE THE NEEDLE OUTSIDE OF THE PATIENT. IT DIDN'T WORK EITHER. WHEN THEY WANTED TO WASH THE EBUS DEVICE, THERE WAS A LARGE LEAK IN THE DEVICE. THE TWO EBUS SCOPES NOW HAD TO BE SENT FOR REPAIRS. THE PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040187 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0030153550 08714729861430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown