BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9492626 · Received December 19, 2019

    Report

    Report Number
    2029046-2019-04029
    Event Type
    Death
    Date Received
    December 19, 2019
    Date of Event
    November 22, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY, THE THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER WAS ASSESSED AS A ¿CONCOMITANT PRODUCT¿ FOR THIS EVENT AND A "NON BIOSENSE, INC. SUSPECTED DEVICE LETTER" FOR THE ¿AGILIS, SL0 AND BRK NEEDLE¿ WAS SENT VIA CERTIFIED/RETURN RECEIPT TO THE FDA. HOWEVER, AFTER FURTHER REVIEW, THIS EVENT WILL BE CONSERVATIVELY REPORTED UNDER THE THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER. PATIENT CODE OF ¿NO CODE AVAILABLE¿ REPRESENTS ¿SURGICAL INTERVENTION." SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT APPROXIMATELY (B)(6), UNDERWENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE AND CARDIAC ARREST RESULTING IN SURGICAL INTERVENTION AND DEATH. PATIENT CAME FOR A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION WITH PRE-EXISTING BI-VENTRICULAR PACEMAKER. EJECTION FRACTION WAS UNKNOWN. TRANSSEPTAL WAS PERFORMED TO ACCESS LV THROUGH THE MITRAL VALVE. CASE WAS COMPLETED AND THERE WAS NO MENTION OF REDUCED BLOOD PRESSURE DURING THE CASE. THERE WERE NO CONCERNS REGARDING PRODUCT OR PRODUCT ISSUES NOTED DURING THE CASE. WITH REMOVAL OF CATHETERS AND AWAKENING FROM ANESTHESIA, IT WAS NOTED THAT THE PATIENT HAD A REDUCED BLOOD PRESSURE. ECHOCARDIOGRAM THEN DEMONSTRATED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND 500 ML OF BLOOD WAS REMOVED. AT THIS TIME, DESPITE PACING, MYOCARDIUM WAS NOT CONTRACTING. RESUSCITATIVE EFFORTS WERE PERFORMED INCLUDING CHEST COMPRESSIONS AND USE OF EPINEPHRINE. PATIENT WAS PLACED ONTO ECMO AND AFTER APPROXIMATELY 90 MINUTES, PATIENT WAS TRANSFERRED TO THE OPERATING ROOM. A TEAR WAS NOTED IN THE AORTA. NO PRODUCT WAS USED IN THE AORTA AND THE TEAR MOST LIKELY OCCURRED WITH TRANSSEPTAL PROCEDURE. AFTER REPAIR, THERE WAS STILL LIMITED CARDIAC FUNCTION AND THE PATIENT EXPIRED AN HOUR OR SO AFTER SURGERY. TRANSSEPTAL PUNCTURE WAS PERFORMED USING AGILIS, SL0 AND BRK NEEDLE. ABLATION WAS PERFORMED PRIOR TO WHEN THE EFFUSION WAS NOTICED. THERE WAS NO EVIDENCE OF STEAM POP. FLOW SETTING WAS SET TO 15ML/MIN (STSF ABOVE 30 WATTS). NO ERROR MESSAGES WERE OBSERVED. PHYSICIANS OPINION OF CAUSE IS BECAUSE OF THE TRANSSEPTAL DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294139 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R ACUNAV 8F-90| NON BWI. - AGILIS, SL0 AND BRK NEEDLE