BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT SLIMLINE SL

    MDR report key: 22470773 · Received July 10, 2025

    Report

    Report Number
    3005099803-2025-03150
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODG
    UDI-DI
    08714729848158
    PMA / PMN Number
    K163058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: ESTIMATED BASED ON THE DATE OF THE 109TH ANNUAL MEETING OF THE JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY ON-DEMAND VIEWING. BLOCK G2: STUDY WS07-12 EUS-HGS IN THE ELDERLY BY KEIGO OSHIRO, NOZOMI OKUNO, AND KAZUO HARA FROM THE AICHI CANCER CENTER. BLOCK H6: PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF PERITONITIS. PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF CHOLECYSTITIS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN EXPECT SLIMLINE SL FROM THE 109TH ANNUAL MEETING OF THE JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY ON-DEMAND VIEWING (WORKSHOP 7) TITLED EUS-HGS IN THE ELDERLY, BY KEIGO OSHIRO, ET AL. PER THE STUDY, THE SAFETY AND CLINICAL OUTCOMES OF EUS-HGS IN ELDERLY PATIENTS WERE EXAMINED RETROSPECTIVELY FROM JANUARY 2017 TO SEPTEMBER 2024. SEVERE COMPLICATIONS MENTIONED INCLUDES SEPTIC SHOCK, PERITONITIS, AND CHOLECYSTITIS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774111 EXPECT SLIMLINE SL BIOPSY NEEDLE ODG BOSTON SCIENTIFIC CORPORATION M00555510 08714729848158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown