BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 20417685 · Received October 10, 2024

    Report

    Report Number
    2124215-2024-63139
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 10, 2024
    Report Date
    July 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. BLOCK H11: BLOCK B5, AND B6 (IMPACT CODES) WERE UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON 20NOV2024.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. BLOCK H11: BLOCK B5 WAS UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON JUNE 27,2025. CLINICAL STUDY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACE OAR INJECTION AND FIDUCIAL MARKERS PLACEMENT UNDER GENERAL ANESTHESIA EXPERIENCED A RECTAL WALL INFILTRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. TWO MONTHS LATER, THE PATIENT REMAINS ASYMPTOMATIC AND IS SCHEDULED FOR FURTHER MEDICAL CHECKS, INCLUDING A FLEXIBLE SIGMOIDOSCOPY AND MAGNETIC RESONANCE IMAGING (MRI).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACE OAR INJECTION AND FIDUCIAL MARKERS PLACEMENT UNDER GENERAL ANESTHESIA EXPERIENCED A RECTAL WALL INFILTRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACE OAR INJECTION AND FIDUCIAL MARKERS PLACEMENT UNDER GENERAL ANESTHESIA EXPERIENCED A RECTAL WALL INFILTRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. TWO MONTHS LATER, THE PATIENT REMAINS ASYMPTOMATIC AND IS SCHEDULED FOR FURTHER MEDICAL CHECKS, INCLUDING A FLEXIBLE SIGMOIDOSCOPY AND MAGNETIC RESONANCE IMAGING (MRI). ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE PATIENT DID NOT COMPLETE THE STEREOTACTIC BODY RADIATION THERAPY (SBRT) TREATMENT; INSTEAD, COMPLETED AN ALTERNATE COURSE OF VOLUMETRIC MODULATED ARC THERAPY (VMAT) TREATMENT, COMPLETED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004956 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-1010 0031939046

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male