BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE

    MDR report key: 22813960 · Received August 15, 2025

    Report

    Report Number
    3005099803-2025-03749
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODG
    UDI-DI
    08714729931782
    PMA / PMN Number
    K160845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: THE REMAINING PRO CODE (PRODUCT CODE) IS ODG; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF PROCEDURE NOT COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING A FINE NEEDLE BIOPSY (FNB) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PRODUCT IS INCLUDED IN THE SCOPE AND DOES NOT FALL OUT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS 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
    2687794 ACQUIRE BIOPSY NEEDLE ODG BOSTON SCIENTIFIC CORPORATION M00555540 0036357827 08714729931782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown