BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 11992874 · Received June 14, 2021

    Report

    Report Number
    3005099803-2021-02852
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA AND XYLOCAINE. AFTER THE SPACEOAR PROCEDURE, WITHIN LESS THAN A MINUTE, THE PATIENT HAD DISCOMFORT, DECREASED BLOOD PRESSURE (SYSTOLIC BLOOD PRESSURE 120 TO 60), AND DECREASED SPO2 (99 TO 75). A VAGAL REFLEX WAS SUSPECTED, BUT THE PATIENT STILL HAD GENERAL REDNESS AND WHEEZING. THE PATIENT WAS TREATED WITH ADRENALINE, SOL MEDROL, AND POLARAMINE. THE PATIENT HAS FULLY RECOVERED AND RECEIVED EXTERNAL BEAM RADIATION THERAPY (EBRT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888852 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-4101

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other