BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 11912284 · Received June 1, 2021

    Report

    Report Number
    3005099803-2021-02457
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    February 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2021, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, 24FEB2021. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE 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 VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT DEVELOPED URINARY RETENTION ISSUES SEVERAL DAYS AFTER THE PROCEDURE. THE PHYSICIAN CONFIRMED THAT THE GEL WAS IN THE CORRECT PLACE AND THE MARKERS WERE IN CORRECT LOCATION. THE PATIENT WAS THEN SCOPED TO ENSURE THERE WERE NO BLOCKAGES IN THE URETHRA, AND FOUND NONE. THE PATIENT HAS ALSO BEEN SUFFERING FROM BENIGN PROSTATIC HYPERPLASIA (BPH) ISSUES. THE PATIENT WAS PRESCRIBED WITH SELF-CATHERIZATION. ON (B)(6) 2021, THE PATIENT COMPLETED HIS RADIATION THERAPY. PATIENT ALSO DEVELOPED AN INFECTION, A BIG RETRO PROSTATIC ABSCESS, SEPTIC POST RADIATION, AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809623 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other