BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 15372624 · Received September 7, 2022

    Report

    Report Number
    3005099803-2022-04932
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    April 1, 2019
    Report Date
    September 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2019, WAS CHOSEN AS THE STUDY WITHIN THE LITERATURE ARTICLE RECEIVED APPROVAL IN APRIL 2019. THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. LITERATURE SOURCE: MAZZOLA R, SICIGNANO G, CUCCIA F, VITALE C, RIGO M, GIAJ-LEVRA N, ET AL. IMPACT OF HYDROGEL PERI-RECTAL SPACER INSERTION ON SEMINAL VESICLES INTRAFRACTION MOTION DURING 1.5 T-MRI- GUIDED ADAPTIVE STEREOTACTIC BODY RADIOTHERAPY FOR LOCALIZED PROSTATE CANCER. BR J RADIOL 2021; 94: 20210521.. (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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "IMPACT OF HYDROGEL PERI-RECTAL SPACER INSERTION ON SEMINAL VESICLES INTRAFRACTION MOTION DURING 1.5 T-MRI GUIDED ADAPTIVE STEREOTACTIC BODY RADIOTHERAPY FOR LOCALIZED PROSTATE CANCER". ADDITIONAL MFR NARRATIVE FOR FULL CITATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNKNOWN SPACEOAR DEVICE WAS IMPLANTED DURING A SPACEOAR IMPLANT PROCEDURE ON AN UNKNOWN DATE. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. IT WAS NOTED THAT THE STUDY ASSOCIATED WITH THE LITERATURE ARTICLE RECEIVED APPROVAL IN APRIL 2019. AFTER THE PROCEDURE, THE PATIENT REPORTED RECTAL TENESMUS. THE PATIENT RECEIVED STEROID THERAPY. THE RECTAL TENESMUS FULLY RESOLVED AFTER RECEIVING THE STEROID THERAPY. FOLLOWING THE SPACEOAR IMPLANT PROCEDURE, THE PATIENT'S RADIOTHERAPY WAS PLANNED TO BEGIN THREE WEEKS AFTER. THE PATIENT WAS TREATED WITH (MAGNETIC RESONANCE IMAGING) MRI-GUIDED PROSTATE STEREOTACTIC BODY RADIOTHERAPY (SBRT). THE PATIENT'S SBRT TREATMENT CONSISTED OF FIVE FRACTIONS OF 7GY WITH A TOTAL DOSE OF 35GY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459333 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION UNK-P-SPACEOAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention