BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 11843348 · Received May 18, 2021

    Report

    Report Number
    3005099803-2021-02200
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. FIDUCIALS WERE ADMINISTERED TRANSPERINEALLY PRIOR TO SPACEOAR IMPLANTATION AND THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. IMAGING WAS DONE POST PROCEDURE AND IT WAS READ AS RECTAL WALL INFILTRATION. IT LOOKED LIKE THE MIDGLAND WAS FINE BUT AT THE APEX, IT WAS CLEAR THAT THERE WAS A RECTAL WALL INVASION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PLANNED EXTERNAL BEAM RADIATION THERAPY (EBRT) WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739529 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1