BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG RF TRANSSEPTAL KIT

    MDR report key: 17587272 · Received August 21, 2023

    Report

    Report Number
    2124215-2023-44602
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    January 24, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K183655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSEPTAL PUNCTURE (TSP) FOR A WATCHMAN PROCEDURE WAS PERFORMED WITH AN NRG TRANSEPTAL NEEDLE. DURING TSP BOTH THE BICAVAL AND THE SAX VIEWS WERE WELL VISUALIZED. MULTIPLE ATTEMPTS TO REPOSITION THE TRANSEPTAL SHEATH WERE MADE AND REWIRING WAS DONE EACH TIME. AN POSTERIOR PERICARDIAL EFFUSION WAS NOTED ON TEE AFTER GOING TRANSEPTAL, THE PHYSICIAN COMMENTED THAT THE TRANSEPTAL SHEATH MAY HAVE SCRAPPED THE RIGHT ATRIUM (RA) WHILE ATTEMPTING TO LAND ON THE SEPTUM. THE EFFUSION STATUS WAS MONITORED AND DID NOT CHANGE DURING PROGRESSION OF THE WATCHMAN PROCEDURE. THE PATIENT'S BLOOD PRESSURE (PB) REMAINED STABLE WITH MINIMAL SUPPORT. THE WATCHMAN PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE PATIENT WAS TAKEN TO POST-ANESTHESIA CARE UNIT AND BEGAN C/O CHEST PAIN ACCOMPANIED BY A DROP IN HER BP. A THORACENTESIS WAS PERFORMED AND 330ML OF FLUID WAS DRAINED. THE PATIENT STABILIZED, THE DRAIN WAS LEFT IN PLACE AND PT WAS ADMITTED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852435 NRG RF TRANSSEPTAL KIT INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention