BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 15962300 · Received December 12, 2022

    Report

    Report Number
    3005099803-2022-07336
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    October 20, 2022
    Report Date
    December 12, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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 PROCEDURE PERFORMED ON OCTOBER 20, 2022. ADDITIONALLY, FIDUCIAL MARKERS WERE PLACED. THE PATIENT FELL AND LAID IN HIS URINE AND FECES FOR TWO DAYS, AND THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM ON (B)(6) 2022. THE PATIENT COMPLAINED OF PELVIC PAIN, RECTAL PAIN, AND DIFFICULTY URINATING. COMPUTERIZED TOMOGRAPHY (CT) IMAGING WAS PERFORMED, AND IT WAS NOTICED THAT THE PATIENT HAS A PELVIC ABSCESS OF 7.6 CM. THE ABSCESS WAS BETWEEN THE PROSTATE GLAND AND THE RECTUM. THE URINARY BLADDER WAS DISTENDED. IT WAS ALSO NOTICED THAT THERE WAS SIGMOID DIVERTICULOSIS. THE APPENDIX WAS NORMAL. AIR FROM THE SOFT TISSUE INFILTRATED THE PERINEUM AND RIGHT GLUTEUS. THE SOFT TISSUE AIR WAS PRESENT AT THE BASE OF THE PENIS AND EXTENDED TO MIDSHAFT OF THE PENIS. THE IMPRESSION OF THE IMAGING INDICATED A PELVIC ABSCESS BETWEEN THE PROSTATE GLAND AND RECTUM AND NEW AIR IN THE PERINEUM AT THE BASE OF THE PENIS AND RIGHT GLUTEUS WAS CONSISTENT WITH NECROTIZING FASCIITIS. THE PATIENT WAS REPORTED TO BE IN THE HEALTH CARE FACILITY AND HAD SEVERAL INCISIONS AND DRAINAGES (I&D'S) AS WELL AS A DIVERTING COLOSTOMY. THE PHYSICIAN BELIEVED THE EVENT WAS A COMPLICATION FROM THE PROCEDURE. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS, DESPITE GOOD FAITH EFFORTS (GFES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419559 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0029558049

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R