BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL

    MDR report key: 25123586 · Received May 8, 2026

    Report

    Report Number
    9616099-2026-00674
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, TWO DEVICE DEFECTS WERE REPORTED IN AN EXOSEAL VASCULAR CLOSURE DEVICE (VCD) CONTROL GROUP DURING A RANDOMIZED CONTROLLED CLINICAL TRIAL. THERE WAS NO REPORTED PATIENT INJURY. THE EVENTS WERE DESCRIBED IN A LITERATURE ARTICLE REGARDING HEMOSTASIS AFTER TRANSFEMORAL INTERVENTION. THE CATALOG NUMBER AND EVENT DATE ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THIS REPORT IS SOURCED FROM LITERATURE ARTICLE BY YU, S., HUANG, Z., LYU, Z., LI, M., YE, B., ZENG, G., XU, J., WANG, H., HOU, J., LIU, Y., ZHAO, Y., GUO, Z., & XIAO, G. (2026).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579926 EXOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.