BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 7724552 · Received July 26, 2018

    Report

    Report Number
    9710452-2018-00030
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    July 26, 2018
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PATIENT COMPLICATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, BAYLIS MEDICAL DEVICES WERE IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. ARTICLE REFERENCE: PEDERSEN M, LEO M, KALLA M, ET AL. MANAGEMENT OF TAMPONADE COMPLICATING CATHETER ABLATION FOR ATRIAL FIBRILLATION: EARLY REMOVAL OF PERICARDIAL DRAINS IS SAFE AND EFFECTIVE AND REDUCES ANALGESIC REQUIREMENTS AND HOSPITAL STAY COMPARED TO CONVENTIONAL DELAYED REMOVAL. JACC: CLINICAL ELECTROPHYSIOLOGY (2017); 3(4): 367-373. AS PER THE ARTICLE, "THE AUTHORS PERFORMED A RETROSPECTIVE DESCRIPTIVE ANALYSIS OF 43 CASES OF TAMPONADE COMPLICATING AFCA FROM 2006 TO 2015, COMPARING PATIENTS IN WHOM THE DRAIN WAS REMOVED EARLY (GROUP EARLY REMOVAL (ER); N 1/4 25) VERSUS TRADITIONAL DELAYED REMOVAL (GROUP DELAYED REMOVAL [DR]; N 1/4 18)...VENOUS ACCESS WAS OBTAINED VIA THE FEMORAL VEINS AND A MULTIPOLAR CATHETER PLACED IN THE CORONARY SINUS (CS). IN CASES PERFORMED UNDER GENERAL ANESTHESIA, ALL TRANSSEPTAL PUNCTURES WERE CARRIED OUT UNDER TRANSESOPHAGEAL GUIDANCE. IN CASES CARRIED OUT UNDER SEDATION, 1 CASE WAS DONE WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE PROBE, SIEMENS, MUNICH, GERMANY) FOR TRANSSEPTAL PUNCTURE GUIDANCE, 1 WAS VIA A PATENT FORAMEN OVALE (PFO)/ATRIAL SEPTIC DEFECT (ASD) AND THE REMAINING CASE WAS DONE WITH FLUOROSCOPIC GUIDANCE ONLY. THE PUNCTURES WERE DONE USING EITHER THE BROCKENBROUGH (MEDTRONIC, INC., MINNEAPOLIS, MINNESOTA), ENDRYS (COOK MEDICAL, BLOOMINGTON, INDIANA) OR THE NRG RF (BAYLIS MEDICAL, MONTREAL, QUEBEC, CANADA) TRANSSEPTAL NEEDLE THROUGH A LONG INTRODUCER SHEATH, USUALLY THE MULLENS (COOK MEDICAL) OR A SHEATH OF THE FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SL SERIES (ST. JUDE MEDICAL, AUSTIN, TEXAS). AT THE OPERATOR'S PREFERENCE, EITHER A SECOND SEPARATE TRANSSEPTAL PUNCTURE WAS DONE OR THE ABLATION CATHETER WAS PASSED THROUGH A SECOND SHEATH, USUALLY AN AGILIS (AGILIS NXT STEERABLE INTRODUCER, ST. JUDE MEDICAL), AND FED ACROSS THE SAME INITIAL PUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563802 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention