BEUDAMED
    FDA Adverse Event Death Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 13252703 · Received January 13, 2022

    Report

    Report Number
    9710452-2022-00005
    Event Type
    Death
    Date Received
    January 13, 2022
    Report Date
    January 13, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. THERE IS NO SUSPECTED DEVICE FAILURE.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, AN ARTICLE [1] WAS IDENTIFIED WITH THE FOLLOWING INFORMATION: "AFTER A SINGLE TRANSSEPTAL PUNCTURE USING A RF NEEDLE (BAYLIS MEDICAL, MONTREAL, CANADA), AN 8.5-FR LONG SHEATH (SL0; ABBOTT, ST. PAUL, MN, USA) AND AN 8.5-FR STEERABLE LONG SHEATH (AGILIS; ABBOTT) WERE ADVANCED INTO THE LEFT ATRIUM (LA) USING GUIDEWIRES. FOLLOWING PULMONARY VENOGRAPHY AND ESOPHAGOGRAPHY, A CIRCULAR MAPPING CATHETER OR A HIGH-DENSITY MAPPING CATHETER (PENTARAY, BIOSENSE-WEBSTER, DIAMOND BAR, CA, USA; OR HDGRID, ABBOTT) VIA AN SL0 SHEATH AND AN ABLATION CATHETER THROUGH AN AGILIS SHEATH WERE INTRODUCED TO THE LA. HEPARIN WAS INITIATED BEFORE TRANSSEPTAL PUNCTURE AND ADMINISTERED TO MAINTAIN AN ACTIVATED CLOTTING TIME OF 300-350 S AFTER CATHETERIZATION OF THE LA...PROCEDURE-RELATED COMPLICATIONS OCCURRED IN 4 OF 119 (3%) PATIENTS, INCLUDING 2 CASES OF PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS, 1 CASE OF SINUS NODE INJURY WITH SVC ISOLATION, AND 1 CASE OF GROIN HEMATOMA. ALL PATIENTS WERE CONSERVATIVELY TREATED WITHOUT LONGTERM SEQUELAE." THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS.[?] HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL COMPANY HAS DECIDED TO SUBMIT THIS REPORT.[?] [1] TAKAMIYA, T., INABA, O., NITTA, J., SATO, A., INAMURA, Y., MURATA, K., ... & SASANO, T. (2020). ASSOCIATION BETWEEN THE LOCATIONS OF NON-PULMONARY VEIN TRIGGERS AND ABLATION OUTCOMES IN REPEAT PROCEDURES AFTER CRYOBALLOON ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 1-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403668 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention