BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 23319539 · Received October 16, 2025

    Report

    Report Number
    2124215-2025-72151
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    January 1, 2021
    Report Date
    October 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, 01/01/2021 IS BASED ON THE DATE RANGE JANUARY 2021- DECEMBER 31, 2022, OF PLACEMENT PROCEDURES FROM THE ARTICLE. BLOCK G2: LITERATURE SOURCE OKA, S., HAYASHIDA, M., SAKAGUCHI, K., & URAKAMI, S. (2025). PREVENTIVE MEASURES FOR SPACEOAR PLACEMENT INSIGHTS FROM INTRAOPERATIVE VIDEO ANALYSIS TO MINIMIZE COMPLICATIONS. UROLOGY VIDEO JOURNAL, 27, 100354. HTTPS://DOI.ORG/10.1016/J.UROLVJ.2025.100354. BLOCK H6: IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION. IMDRF PATIENT CODE E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF PATIENT CODE E1301 CAPTURES THE REPORTABLE EVENT OF DYSURIA. IMDRF DEVICE CODE A1502 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, "PREVENTIVE MEASURES FOR SPACEOAR PLACEMENT: INSIGHTS FROM INTRAOPERATIVE VIDEO ANALYSIS TO MINIMIZE COMPLICATIONS" WRITTEN BY SUGURU OKA ET AL. THE PATIENT RECEIVED ANDROGEN DEPRIVATION THERAPY (ADT) FOR 4 MONTHS PRIOR TO RADIOTHERAPY. THE PATIENT DEVELOPED PROSTATITIS DUE TO HYDROGEL MIGRATION INTO THE URETHRA. TWO WEEKS AFTER THE PLACEMENT PROCEDURE, PRIOR TO RADIATION, THE PATIENT EXPERIENCED DYSURIA AND FEVER. THE PATIENT'S SYMPTOMS IMPROVED AFTER ANTIBIOTIC TREATMENT. DURING THE PROCEDURE, SEVERAL NEEDLE PUNCTURES OCCURRED CAUSING THE HYDROGEL TO BE PLACED IN THE URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392692 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| O