BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 10762835 · Received October 30, 2020

    Report

    Report Number
    3005099803-2020-04894
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES 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) 2020. REPORTEDLY, FIDUCIALS WERE ADMINISTERED TRANSPERINEALLY PRIOR TO SPACEOAR IMPLANTATION. ADDITIONALLY, THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 10-12 WEEKS POST IMPLANT THE GEL WAS DISPLACED. THE SPACEOAR MIGRATED INTO THE PERINEAL TISSUE CAUSING MODERATE TO SEVERE PAIN WITH PALPABLE AND VISUAL LUMP. THE PATIENT CANNOT SIT IN STRAIGHT POSITION AND IS ALSO EXPERIENCING PAINFUL BOWEL MOVEMENTS. REPORTEDLY, 10CC OF HYDROGEL WAS NOTED IN THE PERINEUM. THE PAIN WAS TREATED WITH A NARCOTIC. THE PATIENT CONDITION WAS REPORTED TO HAVE IMPROVED AND NO LONGER EXPERIENCING PAIN NOR A LUMP AT THE PERINEUM. THE PATIENT RECEIVED EXTERNAL BEAM RADIATION THERAPY WITH BRACHYTHERAPY BOOST (15 IMRT FRACTIONS 3750 CGY, BRACHYTHERAPY X 1 FX 1500 CGY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230167 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION UNK-P-SPACEOAR_VUE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other