BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 23952503 · Received January 2, 2026

    Report

    Report Number
    2124215-2026-00185
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 1, 2025
    Report Date
    January 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 12/01/2025, WAS CHOSEN BASED ON DATE THAT THE MANUFACTURER BECAME AWARE OF THE ARTICLE. BLOCK G2: LITERATURE SOURCE - LICHTMAN-MIKOL, S., CORREIA, E. T. D. O., BITTENCOURT, L. K., ZUHOUR, R., ZAORSKY, N. G., CHAUNG, K. V., D'RUMMO, K. A., SHOAG, J. E., VINCE, R. A., CALLAWAY, A. C., PONSKY, L., BARATA, P., MENDIRATTA, P., BROWN, J., GARCIA, J., SPRATT, D. E., & JIA, A. Y. (2025). SALVAGE RE-IRRADIATION FOR PROSTATE CANCER: A CONTEMPORARY PROSPECTIVE EXPERIENCE. INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY, BIOLOGY, PHYSICS, 3272-3273. BLOCK H6: IMDRF DEVICE CODE A150202 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE THAT A SPACEOAR HYDROGEL SYSTEM WAS USED DURING THE STUDY PERFORMED IN THE ARTICLE TITLED "SALVAGE RE-IRRADIATION FOR PROSTATE CANCER: A CONTEMPORARY PROSPECTIVE EXPERIENCE" WRITTEN BY LICHTMAN-MIKOL ET AL. THE STUDY AIMED TO EVALUATE THE FEASIBILITY, TOXICITY, AND PRELIMINARY OUTCOMES OF FOCAL OR WHOLE-GLAND STEREOTACTIC BODY RADIOTHERAPY (SBRT) FOR LOCALLY RECURRENT PROSTATE CANCER FOLLOWING PRIOR DEFINITIVE RADIOTHERAPY, USING ADVANCED IMAGING TECHNIQUES SUCH AS PROSTATE-SPECIFIC MEMBRANE ANTIGEN AND POSITRON EMISSION TOMOGRAPHY (PSMA-PET) AND MAGNETIC RESONANCE IMAGING (MRI). THE STUDY WAS CONDUCTED BETWEEN MAY 2021 AND JANUARY 2025 AND ENROLLED 21 PATIENTS WHO HAD BIOPSY-CONFIRMED LOCAL RECURRENCE AFTER PRIOR PROSTATE RADIOTHERAPY. THE OBJECTIVE WAS TO ASSESS THE EFFECTIVENESS AND SAFETY OF STEREOTACTIC BODY RADIATION THERAPY (SBRT) RE-IRRADIATION. AMONG THESE PATIENTS, 66.7% RECEIVED FOCAL SBRT AND 33.3% RECEIVED WHOLE-GLAND SBRT. ACUTE GRADE 1 2 GENITOURINARY (GU) TOXICITIES OCCURRED IN 28.6% OF PATIENTS, AND ONE PATIENT (4.8%) EXPERIENCED ACUTE GRADE 3 GU TOXICITY (GROSS HEMATURIA) LEADING TO DISCONTINUATION OF TREATMENT. ADDITIONALLY, ONE PATIENT (4.8%) HAD INFILTRATION OF A HYDROGEL SPACER INTO THE RECTAL WALL PRIOR TO RE-IRRADIATION, WHICH REQUIRED ANTIBIOTICS BEFORE TREATMENT COULD PROCEED. NO, LATE GRADE 3 GU OR GASTROINTESTINAL (GI) TOXICITIES WERE REPORTED. THIS EVENT CAPTURES A COMPLICATION INVOLVING THE HYDROGEL SPACER, SPECIFICALLY INFILTRATION INTO THE RECTAL WALL BEFORE SBRT RE-IRRADIATION. THE ISSUE WAS RESOLVED WITH ANTIBIOTICS, AND TREATMENT CONTINUED WITHOUT FURTHER COMPLICATIONS. THIS HIGHLIGHTS THE IMPORTANCE OF CAREFUL PLACEMENT AND MONITORING OF HYDROGEL SPACERS IN SALVAGE RADIOTHERAPY SETTINGS TO AVOID ADVERSE EVENTS SUCH AS RECTAL WALL INJECTION OR PROLONGED PERSISTENCE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3189 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male