BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY

    MDR report key: 20686084 · Received November 14, 2024

    Report

    Report Number
    3005099803-2024-05709
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK G4 (PREMARKET/ 510K#): K151315, K151895, K163248. BLOCK H6: IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF HEPATITIS B ANTIBODY INJECTION THAT WAS GIVEN TO THE PHYSICIAN DUE TO THE NEEDLE STICK. IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF NEEDLE PUNCTURED SHEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE AIRWAY DURING AN ULTRASOUND BRONCHOSCOPY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE PUNCTURED THROUGH THE SIDE OF THE SHEATH AND INJURED THE PHYSICIAN. WHEN THE NEEDLE WAS INSERTED, THE PHYSICIAN GOT INJURED/PUNCTURED. THE PHYSICIAN WENT TO AN INFECTIOUS DISEASE HOSPITAL TO RECEIVE A HEPATITIS B ANTIBODY INJECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223601 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0033997594 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention