BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 11681615 · Received April 16, 2021

    Report

    Report Number
    3005099803-2021-01775
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 VUE WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. FIDUCIALS WERE ADMINISTERED TRANSPERINEALLY PRIOR TO SPACEOAR VUE IMPLANTATION AND THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. THE FIRST SPACEOAR VUE KIT WENT OFF LATERALLY TO THE RIGHT OF THE PROSTATE. A NEW KIT WAS OPENED AND INJECTED IN THE PERIRECTAL FAT PLANE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WILL RECEIVE EXTERNAL BEAM RADIATION THERAPY (EBRT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579304 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0026745057

    Patients

    Seq Age Sex Outcome Treatment
    1