BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE

    MDR report key: 22039017 · Received May 16, 2025

    Report

    Report Number
    3005099803-2025-01870
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 18, 2024
    Report Date
    May 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    UDI-DI
    08714729931782
    PMA / PMN Number
    K160845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: THE REMAINING PRO CODES (PRODUCT CODE) IS ODG; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK E1: INITIAL REPORTED ADDRESS: (B)(6). BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE NEEDLE WAS USED DURING AN ECHO-ENDO PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS CANCELED WHILE USING THE DEVICE. DUE TO THIS EVENT, THE PATIENT'S HOSPITAL STAY WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142620 ACQUIRE BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00555540 0032147325 08714729931782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown