BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 16939752 · Received May 16, 2023

    Report

    Report Number
    3005099803-2023-02425
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    October 1, 2018
    Report Date
    May 16, 2023
    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

    BLOCK A2 (AGE, WEIGHT): THE AVERAGE PATIENT'S AGE AND WEIGHT WERE REPORTED. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK G3: LITERATURE SOURCE JOURNAL ARTICLE: YAMAGUCHI H ET AL. SAFETY OF HYDROGEL SPACERS FOR RECTAL WALL PROTECTION IN PATIENTS WITH PROSTATE CANCER: A RETROSPECTIVE ANALYSIS OF 200 CONSECUTIVE CASES. INT J UROL (2023); 30(4): 401-407. HTTPS://DOI.ORG/10.1111/IJU.15140 . BLOCK H6: DEVICE CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR. PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF ACUTE KIDNEY INJURY. PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF FEVER. PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF INFLAMMATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THROUGH THE ARTICLE "SAFETY OF HYDROGEL SPACERS FOR RECTAL WALL PROTECTION IN PATIENTS WITH PROSTATE CANCER: A RETROSPECTIVE ANALYSIS OF 200 CONSECUTIVE CASES" WRITTEN BY HISASHI YAMAGUCHI, ET AL. ACCORDING TO THE LITERATURE, BETWEEN (B)(6) 2018 AND (B)(6) 2022, 190 PATIENTS UNDERWENT HYDROGEL INJECTION IMPLEMENTATION FOR PROTON BEAM THERAPY. AT THE TIME OF DIAGNOSIS AND BEFORE IMPLANTATION, T3 CASES WITH ONLY ANTERIOR PROSTATE CAPSULAR INVASION ON MAGNETIC RESONANCE IMAGING (MRI) WERE CONSIDERED. FOR THE SPACEOAR IMPLANT PROCEDURES, LOCAL ANESTHESIA CONSISTING OF XYLOCAINE 10ML WAS ADMINISTERED UNDER ECHO GUIDANCE. FIDUCIAL MARKERS WERE ALSO PLACED. THIS REPORT CAPTURES THE EVENT OF A GRADE 3 CORPUS SPONGIOSUM INFILTRATION FOR A PATIENT. ON THE NIGHT OF THE PATIENT'S SPACEOAR IMPLANTATION, THE PATIENT DEVELOPED A FEVER, AND ANTIBIOTICS WERE ADMINISTERED IMMEDIATELY. THE PATIENT ALSO EXPERIENCED INFLAMMATION. THE PATIENT'S SYMPTOMS RESOLVED REPORTEDLY SPONTANEOUSLY WITH NO SEQUELAE. THIS REPORT ALSO CAPTURES THE REPORT OF ANOTHER PATIENT WHO EXPERIENCED URINARY RETENTION WITH A GRADE 3 POSTRENAL ACUTE KIDNEY INJURY. THE PATIENT RETURNED TO HIS PREVIOUS CONDITION WITH NO MAJOR PROBLEMS AFTER HE WAS PROVIDED A URETHRAL CATHETER AND WAS ADMINISTERED ACETATED RINGER'S SOLUTION INFUSION THERAPY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863927 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention