BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACEOAR VUE? SYSTEM - 10ML

    MDR report key: 25305946 · Received May 27, 2026

    Report

    Report Number
    2124215-2026-28125
    Event Type
    Death
    Date Received
    May 27, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK D4:H4 THE EVENT WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DEVICE IMPLANTED. THEREFORE, THERE IS NOT INFORMATION RELATED WITH DEVICE MANUFACTURER DAY. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF DEVICE CODE A150202 CAPTURES THE REPORTABLE EVENT OF GEL FOUND IN UNINTENDED SITE VASCULAR. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF PATIENT CODE E050303 CAPTURES THE REPORTABLE EVENT OF PULMONARY EMBOLISM. IMDRF PATIENT CODE E1036 CAPTURES THE REPORTABLE EVENT OF COLITIS. IMDRF PATIENT CODE E0733 CAPTURES THE REPORTABLE EVENT OF PNEUMONIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPACEOAR VUE PLACEMENT PROCEDURE ON (B)(6) 2026. SUBSEQUENTLY ON (B)(6) 2026, THAT THE PATIENT WAS ADMITTED TO A VETERAN ASSISTANCE (VA) WHERE A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED FINDING CONSISTENT WITH COLITIS AND A POTENTIAL HYDROGEL-RELATED INFECTION. THE IMAGES WERE EVALUATED, IT WAS DETERMINATE THAT AROUND A 20% OF THE HYDROGEL LOOKED TO BE PLACE ANTERIOR TO DENONVILIER'S FASCIA, IT CLIMBED THE VENOUS VESSELS ON THE RIGHT, THE REST OF THE HYDROGEL WAS PLACED IN THE RIGHT PLACE. THE PATIENT WAS ADMITTED DUE TO PNEUMONIA AND WAS ALSO DIAGNOSED WITH PULMONARY EMBOLISM. THE PATIENT REQUIRED ADMISSION TO THE INTENSIVE CARE UNIT (ICU), WHERE LATER ON, (B)(6) 2026, THE PATIENT PASSED AWAY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO GATHER ADDITIONAL INFORMATION, DESPITE THE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44637 SPACEOAR VUE? SYSTEM - 10ML ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1