BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10603826 · Received September 29, 2020

    Report

    Report Number
    2029046-2020-01359
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    August 31, 2020
    Report Date
    August 31, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 10/1/2020 STATING THAT THE 4MM NON-IRRIGATED CATHETER WAS BEING USED FOR MAPPING. ABLATION WAS PERFORMED WITH THIS CATHETER FOR A FEW SECONDS ONLY. SINCE IT WAS CONFIRMED THAT ABLATION WAS PERFORMED FOR A FEW SECONDS WITH THE 4 MM CATHETER, ITS RELATIONSHIP WITH THE ADVERSE EVENT OCCURRENCE CANNOT BE EXCLUDED; THEREFORE, THIS EVENT IS ALSO NOW ASSESSED AS A SERIOUS INJURY UNDER THE 4MM NON-IRRIGATED CATHETER WITH THE AWARENESS DATE OF 10/1/2020. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30394460M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE SYNDROME (AVRT/WPW) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)). DURING THE PROCEDURE, A 4MM NON-IRRIGATED CATHETER WAS BEING USED FOR MAPPING THE LEFT ATRIUM AND WAS TRIED TO BE USED FOR ABLATION; HOWEVER, THE PHYSICIAN NOTICED THEY WERE NOT ACHIEVING ENOUGH CONTACT FORCE, AND DECIDED TO SWITCH TO A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. NO ISSUES WERE EXPERIENCED WITH THE 4MM CATHETER. DURING THE ABLATION PHASE WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, THE PHYSICIAN ATTEMPTED PACING OUT OF ATRIAL TACHYCARDIA BUT WAS UNSUCCESSFUL, SO A CARDIOVERSION WAS PERFORMED. AT THIS POINT THE PATIENT¿S BLOOD PRESSURE DROPPED. AN ECHOCARDIOGRAM USING INTRACARDIAC ECHOCARDIOGRAPHY REVEALED THE EFFUSION. THE PATIENT WENT INTO CARDIAC ARREST, AND CPR WAS PERFORMED. THEN, PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 700 CC OF FLUID FROM THE PERICARDIAL SPACE. PROTAMINE WAS ALSO ADMINISTERED. PATIENT WAS REPORTED IN STABLE CONDITION AND WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) WITH THE PERICARDIAL DRAIN IN PLACE. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN DID NOT BELIEVE THAT BIOSENSE WEBSTER INC. PRODUCTS CONTRIBUTED TO THE PATIENT EVENT. VISITAG AND FORCE DASHBOARD WERE BOTH USED, WITH VISITAG SETTINGS AT 1.5 AND 3.0 WITH NO FORCE OVER-TIME SETTINGS. AVERAGE FORCE WAS USED AS THE VISITAG SETTING. THE PACING LEADS WERE THROUGH THE PIU, AND IT WAS PACING TO PACE OUT OF THE ATRIAL TACHYCARDIA. THERE WASN¿T ANY UNWANTED PACING BEING DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066147 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30394460M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R CARTO 3 SYSTEM| UNK_NAVISTAR RMT 4MM| CARTO 3 SYSTEM| UNK_NAVISTAR RMT 4MM