BEUDAMED
    FDA Adverse Event Death Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 10280119 · Received July 15, 2020

    Report

    Report Number
    9710452-2020-00024
    Event Type
    Death
    Date Received
    July 15, 2020
    Report Date
    July 16, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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 · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, A BAYLIS MEDICAL DEVICE WAS IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICE WAS AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: HAMAYA, R., MIYAZAKI, S., TANIGUCHI, H., KUSA, S., NAKAMURA, H., HACHIYA, H., IESAKA, Y. (2018). MANAGEMENT OF CARDIAC TAMPONADE IN CATHETER ABLATION OF ATRIAL FIBRILLATION: SINGLE-CENTRE 15 YEAR EXPERIENCE ON 5222 PROCEDURES. EUROPACE, 20 (11), 1776-1782. DOI:10.1093/EUROPACE/EUX307. AS PER THIS ARTICLE: "THIS STUDY CONSISTED OF 51 PATIENTS/ PROCEDURES WHO EXPERIENCED CARDIAC TAMPONADE AFTER AF ABLATION BETWEEN 2002 AND 2016 AMONG 5222 CONSECUTIVE AF ABLATION PROCEDURES IN 3483 PATIENTS. IN BRIEF, A TRANS-SEPTAL PUNCTURE WAS PERFORMED UNDER FLUOROSCOPIC GUIDANCE WITH A CONVENTIONAL NEEDLE (ST. JUDE MEDICAL, MINNEAPOLIS, MN, USA) BEFORE NOVEMBER 2013 AND AN RF NEEDLE (BAYLIS MEDICAL, INC., MONTREAL, QUEBEC, CANADA) THEREAFTER. TWO LONG SHEATHS (SL0, ST. JUDE MEDICAL) WERE INTRODUCED INTO BOTH SUPERIOR PULMONARY VEINS (PVS), AND PULMONARY VENOGRAPHY WAS OBTAINED. A PV ANTRUM ISOLATION WAS PERFORMED WITH A DOUBLE-LASSO TECHNIQUE (LASSO, BIOSENSE WEBSTER), DIAMOND BAR, CA, USA) UNDER FLUOROSCOPIC AND ELECTROPHYSIOLOGICAL GUIDANCE UNTIL DECEMBER 2007 AND UNDER GUIDANCE USING A 3D MAPPING SYSTEM (CARTO, BIOSENSE WEBSTER) THEREAFTER. RADIOFREQUENCY CURRENT WAS DELIVERED POINT-BY-POINT WITH A 4MM TIP ABLATION CATHETER (FANTASISTA, JAPAN LIFE LINE, TOKYO, JAPAN) IN THE TEMPERATURE CONTROL MODE, WITH TARGET TEMPERATURE OF 50C AND MAXIMUM POWER OF 35W UNTIL MARCH 2009, AND WITH A 3.5 MM EXTERNALLY IRRIGATED TIP ABLATION CATHETER (THERMOCOOL, BIOSENSE WEBSTER) WITH A POWER OF UP TO 35W, TARGET TEMPERATURE OF GREATER THAN OR EQUAL TO 38C, AND IRRIGATION RATE OF 30ML/MIN THEREAFTER. THE PREDICTORS OF CARDIAC TAMPONADE WERE ANALYSED AMONG 1815 CONSECUTIVE PATIENTS [62.9± 10.5 YEARS, 1356 MEN, 1125 PAROXYSMAL AF, LEFT ATRIAL DIAMETER (LAD) 40.9 ± 6.3MM] UNDERGOING AN INDEX PROCEDURE BETWEEN 2010 AND 2016 IN WHOM WHOLE PATIENT AND PROCEDURAL DATA WERE AVAILABLE. TWENTY-EIGHT (1.54%) PATIENTS EXPERIENCED CARDIAC TAMPONADE, AND THERE WERE NO SIGNIFICANT FACTORS ASSOCIATED WITH THE OCCURRENCE OF TAMPONADE INCLUDING AGE (P= 0.817), BODY MASS INDEX (P = 0.899), GENDER (P= 0.980), TYPE OF AF (P = 0.798), LAD (P= 0.900), USE OF AN RF NEEDLE (P= 0.40), OPERATORS (21 PHYSICIANS, P= 0.844), PEAK ACT VALUE (P= 0.353), AND DOAC USE (P= 0.779) EXCEPT FOR THE USE OF A CRYOBALLOON. THE INCIDENCE OF TAMPONADE WAS SIGNIFICANTLY LOWER WHEN USING A CRYOBALLOON THAN AN RF CATHETER (1/362 VS. 27/1453, P = 0.023). THE INCIDENCE OF TAMPONADE DID NOT DIFFER BETWEEN THE PATIENTS WITH AND WITHOUT THE USE OF CONTACT FORCE CATHETERS (11/526 VS. 17/1289, P = 0.226). THERE WAS 1 DEATH EVENT RELATED TO TAMPONADE AMONG THE 51 CASES, AND THE MORTALITY RATE RESULTING FROM TAMPONADE WAS 0.019% FOR ALL PROCEDURES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743029 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death