BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICROSS EPICARDIAL ACCESS KIT

    MDR report key: 24607285 · Received March 16, 2026

    Report

    Report Number
    3009437315-2026-00001
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 16, 2026
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    DYB
    UDI-DI
    10851498007395
    PMA / PMN Number
    K243954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL DID NOT REPORT THIS EVENT AT THE TIME IT OCCURRED,, THERE WAS NO ALLEGED PRODUCT DEFICIENCY.

    Description of Event or Problem · 0

    THERE WAS A RIGHT VENTRICULAR PERFORATION WITH THE PERICROSS OBTURATOR. PHYSICIAN USED AN AMPLATZER VASCULAR PLUG TO CLOSE THE PERFORATION. PROCEDURE PROCEEDED SUCCESSFULLY GAINING PERICARDIAL ACCESS USING THE PERICROSS DEVICE. PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610734 PERICROSS EPICARDIAL ACCESS KIT CATHETER INTRODUCER DYB CIRCA SCIENTIFIC, INC. PC-1013 UNKNOWN 10851498007395

    Patients

    Seq Age Sex Outcome Treatment
    1