BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE? SYSTEM - 10ML

    MDR report key: 25117964 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-24926
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PATIENT CODE E060109 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF TACHYCARDIA. PATIENT CODE E2321 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HYPOTENSION. PATIENT CODE E060104 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF BRADYCARDIA. PATIENT CODE E0119 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF LOSS OF CONSCIOUSNESS. PATIENT CODE E011903 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SYNCOPE/FAINTING. PATIENT CODE E0726 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HYPOXIA.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE WAS USED DURING A PLACEMENT PROCEDURE ON (B)(6) 2026, UNDER LOCAL ANESTHESIA. FOLLOWING THE PLACEMENT PROCEDURE, THE PATIENT REPORTED NAUSEA, ITCHING AND DYSPNEA AND EXPERIENCED DIAPHORESIS, TACHYCARDIA, HYPOTENSION, HYPOXIA, BRADYCARDIA AND LOSS OF CONSCIOUSNESS. THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY, EVIDENCED BY TACHYCARDIA WITH A HEART RATE OF 137 BEATS PER MINUTE, SEVERE HYPOTENSION WITH A BLOOD PRESSURE OF 69/45 MMHG, AND REDUCED OXYGEN SATURATION TO 90%. THE PATIENT RECEIVED CHEST COMPRESSIONS AND HE WAS RESUSCITATED. AFTER THAT, HE WAS ADMITTED TO THE HOSPITAL AND WAS ASSESSED FOR A POTENTIAL MYOCARDIAL INFARCTION (MI). A MILDLY ELEVATED LEVEL OF TROPONIN WAS DETECTED, BUT A MI WAS RULED OUT. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN THE PHYSICIAN'S ASSESSMENT, THE EVENT WAS ATTRIBUTED TO A POSSIBLE VASOVAGAL RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530414 SPACEOAR VUE? SYSTEM - 10ML ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0037522727 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1