BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9402045 · Received December 3, 2019

    Report

    Report Number
    2029046-2019-03946
    Event Type
    Death
    Date Received
    December 3, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/3/2019, AN ERROR WAS IDENTIFIED IN THE 3500A INITIAL MDR SUBMITTED TO FDA. THE FOLLOWING STATEMENT REPORTED IN ADDNL. MANF. NARRATIVE/CORRCTVE DATA IS INCORRECT, "A MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER." THIS STATEMENT IS INCORRECT BECAUSE THE CUSTOMER DID PROVIDE A LOT NUMBER AND A A MANUFACTURING RECORD EVALUATION WAS PERFORMED. THIS IS THE CORRECT STATEMENT, "A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30255611M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW." MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. INITIAL REPORTER TO INCLUDE TWO CONTACT PERSONS: DR. (B)(6), AND DR. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CORONARY ARTERY STENOSIS REQUIRING SURGICAL INTERVENTION (STENT PLACEMENT), ACUTE MYOCARDIAL INFARCTION, CARDIAC ARREST AND DEATH. THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF PALPITATIONS. TWELVE-LEAD ELECTROCARDIOGRAPHY SHOWED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVC) THAT WERE PREDICTED TO ORIGINATE FROM THE LEFT VENTRICULAR OUTFLOW TRACT BASED ON QRS MORPHOLOGY. RADIOFREQUENCY (RF) CATHETER ABLATION WAS INDICATED FOR THE TREATMENT OF THE PVCS. MAPPING OF THE PVCS WAS PERFORMED AT THE LEFT VENTRICULAR ENDOCARDIAL SURFACE, AORTIC LEFT CORONARY CUSP (LCC), AORTIC RIGHT CORONARY CUSP (RCC) AND THE NON-CORONARY CUSP (NCC). MAPPING BELOW THE LCC AND THE RCC WITH THE ABLATION CATHETER REVEALED A GOOD PACE-MAP, AND THE LOCAL ELECTROGRAM PRECEDED QRS ONSET BY 24 MS. RF ENERGY WAS DELIVERED USING AN IRRIGATED-TIP CATHETER (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER) AT A POWER SETTING OF 20 W. PVCS WERE STILL THERE SO THE PHYSICIAN DECIDED TO INCREASE THE POWER TO 25 W AND THE PVCS TRANSIENTLY DISAPPEARED DURING RF APPLICATIONS BUT RECURRED IMMEDIATELY AFTER APPLICATIONS WERE STOPPED. THE PHYSICIAN AGAIN INCREASED THE POWER TO 40 W. PVCS STOPPED FOR 2 MINUTES AND THEN RECURRED AGAIN. THEREFORE, THE POWER WAS INCREASED TO 43 W, WHICH RESULTED IN ST-T CHANGES AND ABLATION WAS STOPPED AFTER 10 SECONDS. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND RECEIVED SEVERAL SHOCKS AND THE PROCEDURE WAS STOPPED. THE PHYSICIAN REPORTED THAT THE PATIENT HAD LEFT ANTERIOR DESCENDING ARTERY TOTALLY OCCLUDED PROXIMALLY AFTER RADIOFREQUENCY CATHETER ABLATION FOR PVCS ORIGINATING FROM THE LEFT VENTRICULAR OUTFLOW TRACT. ANGIOGRAPHY WAS PERFORMED AND PATIENT HAD LEFT ANTERIOR DESCENDING ARTERY TOTALLY OCCLUDED PROXIMALLY, SO A STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY SHORTLY BEFORE PATIENT PASSED AWAY. THE PATIENT DIED TWO HOURS AFTER THE PROCEDURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS SERIOUS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED AND THE PATIENT CONDITION RELATED TO THE LEFT ANTERIOR DESCENDING ARTERY TOTAL OCCLUSION PROXIMALLY. THERE WAS NO CONCERN OF DEVICE MALFUNCTION. IN PHYSICIAN¿S OPINION THE EVENT WAS RELATED TO PATIENT¿S CONDITION AND PROCEDURE. DASHBOARD, VECTOR AND VISITAG FORCE VISUALIZATION FEATURES WERE USED DURING THE PROCEDURE. VISITAG PARAMETERS FOR WERE STABILITY RANGE 3MM, STABILITY TIME 3 SECONDS, FORCE OVERTIME 25%, MINIMUM FORCE 3G, TIME COLOR OPTION. NO ADDITIONAL FILTERS WERE USED WITH VISITAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200321 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30255611M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death| L| R CARTO 3 SYSTEM| CARTO 3 SYSTEM