BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE

    MDR report key: 23995893 · Received January 7, 2026

    Report

    Report Number
    3005099803-2026-00106
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    October 12, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    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

    D2B: ADDITIONAL PRO CODE (PRODUCT CODE) - ODG. H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF SHEATH PUNCTURED. H11: THE RETURNED ACQUIRE WAS ANALYZED, AND IT WAS DISCOVERED THAT THE WORKING LENGTH WAS KINKED NEAR THE LUER. UNDER MICROSCOPE INSPECTION, THE SHEATH WAS OBSERVED PUNCTURED AND THE TIP OF THE NEEDLE WAS BENT. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS CONFIRMED. WORKING LENGTH KINKED NEAR THE LUER COULD BE DUE TO THE HANDLE WAS NOT GRABBED OR SECURED CAREFULLY, OR MAYBE THE WEIGHT OF THE DEVICE ITSELF CAN BEND THE WORKING LENGTH. SINCE THE NEEDLE WAS OBSERVED TO BE KINKED, DURING ACTUATION OF THE DEVICE IT DID NOT EMERGE AS INTENDED AND INSTEAD PUNCTURED THE SHEATH. PROCEDURAL FACTORS AS HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), MOST LIKELY CONTRIBUTED TO THE BENDING OF THE NEEDLE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY (EUS FNB) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE NEEDLE OF THE ACQUIRE WAS BENT. ANOTHER ACQUIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHEATH PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54958 ACQUIRE BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00555540 0036195209 08714729931782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown