BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 16030674 · Received December 21, 2022

    Report

    Report Number
    3019751610-2022-00074
    Event Type
    Injury
    Date Received
    December 21, 2022
    Report Date
    December 21, 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
    003

    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 PROCEDURES, BAYLIS MEDICAL COMPANY 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 WHERE A BAYLIS MEDICAL COMPANY INC. DEVICE WAS USED FOR TRANSSEPTAL PUNCTURE FOR ABLATION PROCEDURES: "THE RIGHT FEMORAL VEIN AND LEFT MEDIAN CUBITAL VEIN OF THE FOREARM WERE USED TO GAIN VASCULAR ACCESS. A 6FR 20-POLE STEERABLE CATHETER (BEEAT, JAPAN LIFELINE CO., LTD, JAPAN), CAPABLE OF RECORDING FROM THREE SITES SIMULTANEOUSLY, WAS INSERTED THROUGH THE LEFT MEDIAN CUBITAL VEIN AND PLACED INTO THE CORONARY SINUS, THE RIGHT ATRIUM, AND THE SUPERIOR VENA CAVA FOR PACING, RECORDING, AND INTERNAL CARDIOVERSION (23). AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) PROBE (ACUNAV OR SOUNDSTAR, BIOSENSE WEBSTER, CA, UNITED STATES) WAS PLACED ON THE RIGHT ATRIAL SEPTUM VIA THE FEMORAL VEIN. TRANSSEPTAL ACCESS TO THE LEFT ATRIUM WAS ESTABLISHED USING AN RF NEEDLE (BAYLIS MEDICAL, MONTREAL, CANADA) AND AN 8FR OR 8.5FR LONG SHEATH (SL0, ABBOTT, (B)(4), UNITED STATES) UNDER FLUOROSCOPIC AND ICE GUIDANCE. DURING THE PROCEDURE, A STATE OF SYSTEMIC ANTICOAGULATION WAS ENSURED THROUGH REPETITIVE INTRAVENOUS HEPARIN ADMINISTRATION TO MAINTAIN AN ACTIVATED CLOTTING TIME OF 300-350 SECONDS. A 7FR ESOPHAGEAL CATHETER (ESOPHASTAR, JAPAN LIFELINE CO. , LTD, JAPAN) WAS INSERTED NASALLY AND ADVANCED INTO THE ESOPHAGUS, POSTERIOR TO THE LEFT ATRIUM, UNDER FLUOROSCOPIC GUIDANCE. NO SEVERE COMPLICATIONS, SUCH AS PROCEDURE-RELATED DEATH, ATRIAL-ESOPHAGEAL FISTULA, OR STROKE, EXCEPT FOR ONE CASE OF CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, WERE OBSERVED. ONE PATIENT IN THE CB GROUP HAD A 75% PULMONARY VEIN STENOSIS IN THE EARLY POST-ABLATION PERIOD, WHICH IMPROVED TO ABOUT 25% STENOSIS AFTER ONE YEAR DURING FOLLOW-UP. FOUR PATIENTS HAD FEMORAL PUNCTURE-SITE HEMATOMAS, BUT NONE OF THEM REQUIRED VASCULAR INTERVENTION OR BLOOD TRANSFUSION." 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 PROCEDURES, BAYLIS MEDICAL COMPANY HAS DECIDED TO SUBMIT THIS REPORT. [1] TERATA, K., ABE, Y., TASHIRO, H., KATO, M., SASAKI, F., & WATANABE, H. (2022). COMPARISON OF RADIOFREQUENCY AND CRYOBALLOON PULMONARY VEIN ABLATION FOR THE EARLY AND LATE RECURRENCE OF ATRIAL FIBRILLATION. INTERNAL MEDICINE (TOKYO, JAPAN), 61(22), 3315-3322. HTTPS://DOI.ORG/10.2169/INTERNALMEDICINE.9367-22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2918807 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R