BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 23791459 · Received December 12, 2025

    Report

    Report Number
    2124215-2025-90653
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    October 28, 2025
    Report Date
    January 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00850009803009
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A150202 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E232401 CAPTURES THE REPORTABLE EVENT OF FECAL INCONTINENCE. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E2315 CAPTURES THE REPORTABLE EVENT OF FLUID DISCHARGE. IMDRF PATIENT CODE E2339 CAPTURES THE REPORTABLE EVENT OF ULCER. IMDRF PATIENT CODE E2314 CAPTURES THE REPORTABLE EVENT OF FISTULA.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION BLOCK B5 AND H6 HAVE BEEN UPDATED, THE PATIENT CODE E2314 FISTULA WAS REMOVED DUE TO THE NEW INFORMATION. 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 COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A150202 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E232401 CAPTURES THE REPORTABLE EVENT OF FECAL INCONTINENCE. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E2315 CAPTURES THE REPORTABLE EVENT OF FLUID DISCHARGE. IMDRF PATIENT CODE E2339 CAPTURES THE REPORTABLE EVENT OF ULCER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPACEOAR VUE PLACEMENT PROCEDURE WITH FIDUCIAL MARKER SON (B)(6) 2025. A DIGITAL RECTAL EXAMINATION (DRE) WAS PERFORMED AT THE END OF THE PROCEDURE AND THERE WERE NO SIGNS OF PROBLEMS. A PLANNING COMPUTED TOMOGRAPHY (CT) WAS PERFORMED ON (B)(6) 2025. THERE WAS CONCERN OF A RECTAL WALL INFILTRATION OF THE HYDROGEL AND THE PATIENT WAS CONSTIPATED AT THE TIME. THE PATIENT UNDERWENT RADIATION TREATMENT AS PLANNED. ON (B)(6) 2025, THE PATIENT STARTED EXPERIENCING PAIN IN THE RECTUM, BLEEDING AND SOME FECAL INCONTINENCE. THE PATIENT REPORTED PASSING HYDROGEL THROUGH THEIR STOOLS, THEREFORE WAS ADMITTED TO THE MEDICAL WARD. THE PATIENT IS CURRENTLY STABLE WITH NO FURTHER SYMPTOMS OR ISSUES. A SIGMOIDOSCOPY LATER CONFIRMED A PERFORATION IN THE RECTUM, AND DURING THE PROCEDURE, THE SURGEON SUCCESSFULLY REMOVED THE ENTIRE HYDROGEL IN ONE PIECE. THE PATIENT WAS OFFERED A DIVERSION. THE PATIENT IS CLINICALLY WELL AND NOW IS WAITING FOR THE PLAN OF THE COLORECTAL SURGEON. THE PATIENT IS AVOIDING HARD STOOLS AND IS CURRENTLY ON AUGMENTIN. THE PATIENT IS CURRENTLY ASYMPTOMATIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPACEOAR VUE PLACEMENT PROCEDURE WITH FIDUCIAL MARKER SON (B)(6) 2025. A DIGITAL RECTAL EXAMINATION (DRE) WAS PERFORMED AT THE END OF THE PROCEDURE AND THERE WERE NO SIGNS OF PROBLEMS. A PLANNING COMPUTED TOMOGRAPHY (CT) WAS PERFORMED ON (B)(6) 2025. THERE WAS CONCERN OF A RECTAL WALL INFILTRATION OF THE HYDROGEL AND THE PATIENT WAS CONSTIPATED AT THE TIME. THE PATIENT UNDERWENT RADIATION TREATMENT AS PLANNED. ON (B)(6) 2025, THE PATIENT STARTED EXPERIENCING PAIN IN THE RECTUM, BLEEDING AND SOME FECAL INCONTINENCE. THE PATIENT REPORTED PASSING HYDROGEL THROUGH THEIR STOOLS, THEREFORE WAS ADMITTED TO THE MEDICAL WARD. THE PATIENT IS CURRENTLY STABLE WITH NO FURTHER SYMPTOMS OR ISSUES. A SIGMOIDOSCOPY LATER CONFIRMED A PERFORATION IN THE RECTUM, AND DURING THE PROCEDURE, THE SURGEON SUCCESSFULLY REMOVED THE ENTIRE HYDROGEL IN ONE PIECE. THE PATIENT WAS OFFERED A DIVERSION. THE PATIENT IS CLINICALLY WELL AND NOW IS WAITING FOR THE PLAN OF THE COLORECTAL SURGEON. THE PATIENT IS AVOIDING HARD STOOLS AND IS CURRENTLY ON AUGMENTIN. THE PATIENT IS CURRENTLY ASYMPTOMATIC. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT ONLY HAS AN ULCER, THERE ARE NO SIGNS OF FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2695651 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-1010 00850009803009

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other| R