BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE

    MDR report key: 25256608 · Received May 22, 2026

    Report

    Report Number
    3005099803-2026-02028
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    UDI-DI
    08714729931829
    PMA / PMN Number
    K223616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): ADDITIONAL PRO CODE: ODG BLOCK H6: DEVICE CODE A041001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE PUNCTURED SHEATH. DEVICE CODE A0501IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE EUS FNB NEEDLE 19 G FLEX WAS USED FOR AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE NEEDLE WOULD NOT EXTEND OUT OF THE SHEATH. WHEN THE DEVICE WAS TRYING TO BE REMOVED FROM THE SCOPE, THE NEEDLE BROKE AND DETACHED FROM THE DEVICE. WHILE THE DEVICE WAS TAKING OUT OF THE SCOPE, THE NEEDLE CAUSED DAMAGED TO THE SCOPE AND PUNCTURED THE SHEATH. ANOTHER ACQUIRE EUS FNB NEEDLE 19 G FLEX WAS USED TO SUCCESSFULLY CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529524 ACQUIRE BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00555580 0038541306 08714729931829

    Patients

    Seq Age Sex Outcome Treatment
    1