BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM - 10ML

    MDR report key: 20783240 · Received November 26, 2024

    Report

    Report Number
    2124215-2024-73212
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKH6: IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E2304 CAPTURES THE REPORTABLE EVENT OF CHILLS. IMDRF PATIENT CODE E020204 CAPTURES THE REPORTABLE EVENT OF MALAISE. IMDRF PATIENT CODE E1008 CAPTURES THE REPORTABLE EVENT OF DIARRHEA. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E231501 CAPTURES THE REPORTABLE EVENT OF PURULENT DISCHARGE.

    Additional Manufacturer Narrative · 0

    RESPONSE TO THE FDA MW5162550 WAS REPORTED TO BOSTON SCIENTIFIC ON DECEMBER 06, 2024. BLOCK B5 AND H6 HAVE BEEN UPDATED WITH THE INFORMATION PROVIDED. BLOCKH6: IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E2304 CAPTURES THE REPORTABLE EVENT OF CHILLS. IMDRF PATIENT CODE E020204 CAPTURES THE REPORTABLE EVENT OF MALAISE. IMDRF PATIENT CODE E1008 CAPTURES THE REPORTABLE EVENT OF DIARRHEA. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E231501 CAPTURES THE REPORTABLE EVENT OF PURULENT DISCHARGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACEOAR PLACEMENT PROCEDURE DEVELOPED DIARRHEA, MALAISE, CHILLS, PELVIC PAIN, AND FOUL-SMELLING WHITE DRAINAGE PER RECTUM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ABOUT ONE MONTH AFTER THE PROCEDURE, WHERE HE WAS DIAGNOSED WITH A CAVITARY RECTAL ABSCESS THAT WAS TREATED WITH INCISION AND DRAINAGE. THE PATIENT WAS PRESCRIBED FLAGYL AND CIPRO FOR THE ONGOING PAIN. THE PHYSICIAN STATED THAT THEY WOULD PROCEED WITH A CONSERVATIVE TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACEOAR PLACEMENT PROCEDURE DEVELOPED DIARRHEA, MALAISE, CHILLS, PELVIC PAIN, AND FOUL-SMELLING WHITE DRAINAGE PER RECTUM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ABOUT ONE MONTH AFTER THE PROCEDURE, WHERE HE WAS DIAGNOSED WITH A CAVITARY RECTAL ABSCESS THAT WAS TREATED WITH INCISION AND DRAINAGE. THE PATIENT WAS PRESCRIBED FLAGYL AND CIPRO FOR THE ONGOING PAIN. THE PHYSICIAN STATED THAT THEY WOULD PROCEED WITH A CONSERVATIVE TREATMENT. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 06, 2024*** IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL IN THE EMERGENCY ROOM FOR IMAGING AND ANTIBIOTICS. A LARGE THICK WALLED CAVITARY MASS BETWEEN THE PROSTATE AND THE RECTUM WAS IDENTIFIED, IT CONTAINED GAS WITHIN THE CAVITY, THERE WAS CONCERNING FOR AN ABSCESS, FOR WHICH UNDERLYING FISTULA FROM THIS MASS TO THE RECTUM WAS NOT EXCLUDED. IT WAS MENTIONED THAT THE HYPERDENSITY WITHIN THE CAVITARY LESION MAY REPRESENT THE INJECTION OF THE HYDROGEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575880 SPACEOAR VUE SYSTEM - 10ML ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0034516920 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R