BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRELUDESYNC EVO RADIAL COMPRESSION DEVICE

    MDR report key: 21984388 · Received May 8, 2025

    Report

    Report Number
    3011642792-2025-00063
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 8, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    DXC
    UDI-DI
    00884450567876
    PMA / PMN Number
    K180723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE AND DEVICE HISTORY RECORD CANNOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120769 PRELUDESYNC EVO RADIAL COMPRESSION DEVICE RADIAL COMPRESSION DEVICE DXC MERIT MEDICAL SYSTEMS MEXICO 00884450567876

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention STAT SEAL