BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 17438111 · Received August 1, 2023

    Report

    Report Number
    3005099803-2023-04068
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    June 8, 2023
    Report Date
    May 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G2: U0720 SABRE SPACEOAR SYSTEM RWS CLINICAL STUDY. BLOCK H6: IMDRF PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION.

    Additional Manufacturer Narrative · 0

    CORRECTION B2 HAS BEEN UPDATE. ADDITIONAL INFORMATION BLOCK B5 HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED APRIL 18, 2024. ADDITIONAL INFORMATION BLOCK B5 HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED AUGUST 01, 2023. BLOCK G2: U0720 SABRE SPACEOAR SYSTEM RWS CLINICAL STUDY. BLOCK H6: IMDRF PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION BLOCK B5 HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED AUGUST 01, 2023. BLOCK G2: (B)(6) SABRE SPACEOAR SYSTEM RWS CLINICAL STUDY. BLOCK H6: IMDRF PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT CLINICAL TRIAL STUDY PROCEDURE ON (B)(6) 2023. THREE FIDUCIAL MARKERS WERE SUCCESSFULLY PLACED PRIOR TO PROCEDURE. THE HYDROGEL PLACEMENT WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING (MRI). DURING THE PROCEDURE, NO ADVERSE EVENTS OR DEVICE OBSERVATIONS WERE NOTED. THE PROCEDURE WAS COMPLETED UNDER NITROUS OXIDE. ON (B)(6) 2023, THE PATIENT EXPERIENCED NON-SERIOUS RECTAL BLEEDING AND RECTAL PAIN, NO ACTIONS WERE TAKEN. THE RELATIONSHIP BETWEEN THE DEVICE AND THE IMPLANT PROCEDURE AND THE RECTAL BLEEDING AND PAIN WERE REPORTED AS POSSIBLY RELATED. THE RELATIONSHIP BETWEEN THE RECTAL PAIN AND FIDUCIAL MARKER PLACEMENT WAS ALSO NOTED AS PROBABLY RELATED. THESE EVENTS WERE REPORTED AS ONGOING AT THE TIME OF THIS REPORT. THE SAME DAY, THE PATIENT ALSO EXPERIENCED URINARY HESITANCY. THE PATIENT RECEIVED MEDICATION; HOWEVER, THE TYPE OF MEDICATION WAS NOT SPECIFIED. THE URINARY HESITANCY EVENT WAS REPORTED AS ONGOING AT THE TIME OF THIS REPORT. THE RELATIONSHIP BETWEEN URINARY HESITANCY AND THE SPACEOAR DEVICE WAS NOTED AS BEING PROBABLY RELATED AND PROBABLY RELATED TO THE FIDUCIAL MARKER PLACEMENT AS WELL. THE PATIENT CURRENT STATUS WAS UNKNOWN AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT CLINICAL TRIAL STUDY PROCEDURE ON (B)(6) 2023. THREE FIDUCIAL MARKERS WERE SUCCESSFULLY PLACED PRIOR TO PROCEDURE. THE HYDROGEL PLACEMENT WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING (MRI). DURING THE PROCEDURE, NO ADVERSE EVENTS OR DEVICE OBSERVATIONS WERE NOTED. THE PROCEDURE WAS COMPLETED UNDER NITROUS OXIDE. ON (B)(6) 2023, THE PATIENT EXPERIENCED NON-SERIOUS RECTAL BLEEDING AND RECTAL PAIN, NO ACTIONS WERE TAKEN. THE RELATIONSHIP BETWEEN THE DEVICE AND THE IMPLANT PROCEDURE AND THE RECTAL BLEEDING AND PAIN WERE REPORTED AS POSSIBLY RELATED. THE RELATIONSHIP BETWEEN THE RECTAL PAIN AND FIDUCIAL MARKER PLACEMENT WAS ALSO NOTED AS PROBABLY RELATED. THESE EVENTS WERE REPORTED AS ONGOING AT THE TIME OF THIS REPORT. THE SAME DAY, THE PATIENT ALSO EXPERIENCED URINARY HESITANCY. THE PATIENT RECEIVED MEDICATION; HOWEVER, THE TYPE OF MEDICATION WAS NOT SPECIFIED. THE URINARY HESITANCY EVENT WAS REPORTED AS ONGOING AT THE TIME OF THIS REPORT. THE RELATIONSHIP BETWEEN URINARY HESITANCY AND THE SPACEOAR DEVICE WAS NOTED AS BEING PROBABLY RELATED AND PROBABLY RELATED TO THE FIDUCIAL MARKER PLACEMENT AS WELL. THE PATIENT CURRENT STATUS WAS UNKNOWN AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED AUGUST 01, 2023; IT WAS FURTHER REPORTED THAT THE PATIENT URINARY HESITANCY WAS TREATED WITH TAMSULOSIN. THE PATIENT STARTED WITH HIS RADIATION TREATMENT DELIVERED VIA LINAC. IT WAS ALSO REPORTED THAT THE PATIENT HAS COMPLETED 5 FRACTIONS FROM (B)(6) 2023, TO (B)(6) 2023. THE PATIENT'S URINARY HESITANCY WAS REPORTED AS ONGOING AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED ON APRIL 18, 2024: IT WAS FURTHER REPORTED THAT THE EVENT OF PAIN WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT CLINICAL TRIAL STUDY PROCEDURE ON (B)(6) 2023. THREE FIDUCIAL MARKERS WERE SUCCESSFULLY PLACED PRIOR TO PROCEDURE. THE HYDROGEL PLACEMENT WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING (MRI). DURING THE PROCEDURE, NO ADVERSE EVENTS OR DEVICE OBSERVATIONS WERE NOTED. THE PROCEDURE WAS COMPLETED UNDER NITROUS OXIDE. ON (B)(6) 2023, THE PATIENT EXPERIENCED NON-SERIOUS RECTAL BLEEDING AND RECTAL PAIN, NO ACTIONS WERE TAKEN. THE RELATIONSHIP BETWEEN THE DEVICE AND THE IMPLANT PROCEDURE AND THE RECTAL BLEEDING AND PAIN WERE REPORTED AS POSSIBLY RELATED. THE RELATIONSHIP BETWEEN THE RECTAL PAIN AND FIDUCIAL MARKER PLACEMENT WAS ALSO NOTED AS PROBABLY RELATED. THESE EVENTS WERE REPORTED AS ONGOING AT THE TIME OF THIS REPORT. THE SAME DAY, THE PATIENT ALSO EXPERIENCED URINARY HESITANCY. THE PATIENT RECEIVED MEDICATION; HOWEVER, THE TYPE OF MEDICATION WAS NOT SPECIFIED. THE URINARY HESITANCY EVENT WAS REPORTED AS ONGOING AT THE TIME OF THIS REPORT. THE RELATIONSHIP BETWEEN URINARY HESITANCY AND THE SPACEOAR DEVICE WAS NOTED AS BEING PROBABLY RELATED AND PROBABLY RELATED TO THE FIDUCIAL MARKER PLACEMENT AS WELL. THE PATIENT CURRENT STATUS WAS UNKNOWN AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ***ADDITIONAL INFORMATION RECEIVED AUGUST 01, 2023*** IT WAS FURTHER REPORTED THAT THE PATIENT URINARY HESITANCY WAS TREATED WITH TAMSULOSIN. THE PATIENT STARTED WITH HIS RADIATION TREATMENT DELIVERED VIA LINAC. IT WAS ALSO REPORTED THAT THE PATIENT HAS COMPLETED 5 FRACTIONS FROM (B)(6) 2023, TO (B)(6) 2023. THE PATIENT'S URINARY HESITANCY WAS REPORTED AS ONGOING AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335440 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0031275566 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention