BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF NEEDLE

    MDR report key: 18694534 · Received February 13, 2024

    Report

    Report Number
    2124215-2024-07316
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    December 8, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 A NRG RF NEEDLE WAS SELECTED FOR USE DURING A MITRA CLOP PROCEDURE AND A PERFORATION WAS NOTED. DURING TRANSSEPTAL PUNCTURE FOR A MITRA CLIP PROCEDURE, A PERFORATION WAS CAUSED BY THE BOSTON SCIENTIFIC PUNCTURE NEEDLE. AFTER TRANSEPTAL PUNCTURE, THE PATIENT'S BLOOD PRESSURE DECREASED BY APPROXIMATELY 60 MMHG, SO THE CARDIAC TEAM ATTEMPTED SURGICAL DRAINAGE. THE ENTRY POINT WAS NOTED THROUGH THE RIGHT ATRIUM VIA AN ECHOCARDIOGRAM AND TREATMENT WAS PERFORMED. AFTER THE BLOOD PRESSURE STABILIZED, THE SURGERY WAS RESUMED. THE MITRA CLIP WAS PLACED ON THE A2P2 AND THE MR WAS REDUCED TO LESS THAN A GRADE 1. AFTER EVACUATING THE MITRA CLIP STEERABLE GUIDE CATHETER FROM LEFT ATRIUM, THE ECHOCARDIOGRAM SHOWED A LARGE HOLE IN FOSSA. THERE WAS NO TREATMENT REQUIRED FOR THE HOLE IN THE FOSSA AND IT WAS NOT RELATED TO THE ADVERSE EVENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE, AND THE PATIENT HAS BEEN DISCHARGED. BOSTON SCIENTIFIC BAYLIS NEEDLE: 1. MODEL NRG-E-HF-71-C1-J, LOT:NGFB121222 AND 2. MODEL NRG-E-HF-71-C0-J, LOT:NGFD310723.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225918 RF NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC. NGFD310723

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention