BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 18379537 · Received December 21, 2023

    Report

    Report Number
    2124215-2023-71837
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    October 5, 2023
    Report Date
    January 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR.

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. PATIENT CODE E2006 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ULCER. PATIENT CODE E2339 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF EROSION. BLOCK H11: BLOCKS B5, H1, H6 WERE UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON JANUARY 04, 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A PLACEMENT PROCEDURE UNDER GENERAL ANESTHESIA PERFORMED ON (B)(6) 2023. ADDITIONALLY, FIDUCIAL MARKERS WERE PLACED TRANSPERINEALLY, AFTER UNDERGOING TWO SESSIONS OF RADIATION THERAPY, THE PATIENT HAS REPORTED A NOTABLE CHANGE IN BOWEL SENSATIONS. SUBSEQUENT CONE BEAM COMPUTERIZED TOMOGRAPHY (CT) IMAGING INDICATED THE POSSIBLE MIGRATION OF THE GEL INTO THE LUMEN OF THE RECTUM. AS A RESULT OF THIS EVENT, THE PATIENT'S RADIATION TREATMENT WAS DELAYED. FURTHER ASSESSMENTS WILL BE CONDUCTED TO DETERMINE THE APPROPRIATE COURSE OF ACTION. IT WAS REPORTED THAT THE PATIENT WAS NOT EXPERIENCING PAIN BUT HAS REPORTED A SENSATION OF PRESSURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A PLACEMENT PROCEDURE UNDER GENERAL ANESTHESIA PERFORMED ON (B)(6) 2023. ADDITIONALLY, FIDUCIAL MARKERS WERE PLACED TRANSPERINEALLY, AFTER UNDERGOING TWO SESSIONS OF RADIATION THERAPY, THE PATIENT HAS REPORTED A NOTABLE CHANGE IN BOWEL SENSATIONS. SUBSEQUENT CONE BEAM COMPUTERIZED TOMOGRAPHY (CT) IMAGING INDICATED THE POSSIBLE MIGRATION OF THE GEL INTO THE LUMEN OF THE RECTUM. AS A RESULT OF THIS EVENT, THE PATIENT'S RADIATION TREATMENT WAS DELAYED. FURTHER ASSESSMENTS WILL BE CONDUCTED TO DETERMINE THE APPROPRIATE COURSE OF ACTION. IT WAS REPORTED THAT THE PATIENT WAS NOT EXPERIENCING PAIN BUT HAS REPORTED A SENSATION OF PRESSURE. ADDITIONAL INFORMATION. IT WAS REPORTED THAT THAT A COLONOSCOPY WAS PERFORMED, AND IT WAS OBSERVED A TINY ULCERATION IN THE RECTAL WALL WITH THE GEL HANGING DOWN AND PROTRUDING THROUGH THE RECTAL WALL INTO THE LUMEN. THEY ADDRESSED THE SITUATION BY USING A CLIP TO SECURE THE HYDROGEL THAT WAS HANGING DOWN THROUGH THE RECTAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277923 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male