BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 16765211 · Received April 18, 2023

    Report

    Report Number
    3005099803-2023-02016
    Event Type
    Death
    Date Received
    April 18, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE COMPLAINANT REPORTED THE APPROXIMATE PROCEDURE AND DEATH DATE OF THE EVENT WAS ON MARCH 02, 2023. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT, DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS USED DURING A SPACEOAR VUE IMPLANT PROCEDURE ON AN UNKNOWN DATE, APPROXIMATED TO BE FOUR WEEKS BEFORE BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT. THE PATIENT WAS GIVEN ANTIBIOTICS BEFORE AND AFTER THE PROCEDURE (KEFLEX / CEPHALEXIN 1 TABLET IN THE MORNING AND ONE ABLET IN THE EVENING). THE PATIENT WAS ALSO GIVEN A PRESCRIPTION OF NORCO (HYDROCODONE/ACETAMINOPHEN 5/325 MG), 0.5MG ATIVAN (TAKEN 1 HOUR PRIOR TO PROCEDURE) BEFORE PROCEDURE. THE SKIN WAS SPRAYED WITH ETHYL CHLORIDE SPRAY, AND THE INJECTION AREA WAS CLEANED WITH CHLORHEXIDINE PREP BEFORE INJECTING LIDOCAINE. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHETIC (2% LIDOCAINE 8-9MLTOTAL; 2ML WERE PLACED UNDER THE SKIN, THE REST WAS PLACED AT APEX OF PROSTATE), FOLLOWED BY HYDRO-DISSECTION WITH 2-3 ML OF SALINE, AND ASPIRATION WAS PERFORMED AND CONFIRMED THERE WAS NO BLOOD (THE NEEDLE WAS IN THE RIGHT PLACE). THE HYDROGEL WAS PLACED UNDER ULTRASOUND GUIDANCE WITH UROJET LIDOCAINE GEL IN THE RECTUM. AFTER THE INJECTION OF THE HYDROGEL THE STEPPER PROBE WAS REMOVED, THE PATIENTS' LEGS WERE LOWERED, AND THE PATIENT WAS INSTRUCTED TO STAY LAYING DOWN TO AVOID BEING LIGHTHEADED. AFTER 10-15 SECONDS THE PATIENT SAID THAT HE WAS LIGHTHEADED. TEN (10) SECONDS LATER THE PATIENT ROLLED TO HIS SIDE AND ATTEMPT TO VOMIT, DRY HEAVED, THEN THE PATIENT LAID BACK DOWN AND SAID HE WASN'T FEELING OK. THE PATIENT DRIED HEAVED AGAIN AND LAID DOWN. THE PATIENT WAS CYANOTIC, AND LOST CONSCIOUSNESS. IT WAS REPORTED THE PATIENT WAS BREATHING BUT WAS NOT RESPONSIVE, RAPID RESPONSE TURNED INTO CODE BLUE, THE PATIENT WAS INTUBATED AND WAS INJECTED WITH EPINEPHRINE AND SODIUM BICARBONATE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED FOR 20 MINUTES AND SINCE THERE WAS NO SHOCKABLE RHYTHM THE PATIENT WAS NEVER SHOCKED. THE PATIENT WAS THEN PRONOUNCED DEAD. AN AUTOPSY WAS PERFORMED AND REPORTED THE CAUSE OF DEATH AS NATURAL CAUSES DUE TO HYPERTENSIVE ATHEROSCLEROTIC CARDIAC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187794 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death