BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18897356 · Received March 13, 2024

    Report

    Report Number
    2029046-2024-00825
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 13, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. WHILE BURNING IN THE LEFT ATRIUM OF THE HEART, THE PATIENT'S BLOOD PRESSURE BEGAN DROPPING. THE PHYSICIAN CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), BUT INITIALLY COULD NOT CONFIRM AN ISSUE. THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP, THE PHYSICIAN CHECKED ICE (ECHO) A SECOND TIME, MOVED TOWARD THE RIGHT ATRIUM AREA OF THE HEART, CONFIRMED AN EFFUSION, AND ORDERED THAT THE PATIENT BE "TAPPED". THE PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED USING BOTH ICE AND AN ULTRASOUND. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 850 CCS OF FLUID WAS REMOVED. THEY WERE ABLE TO PUT 250 CCS OF FLUID BACK INTO THE PATIENT. THE CALLER REPORTED THAT THE PATIENT WAS CURRENTLY IN STABLE CONDITION. BWI THERAPEUTIC/DIAGNOSTIC PRODUCTS THAT WERE IN USE DURING THE PROCEDURE WERE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, CORONARY SINUS (CS) CATHETER, VIZIGO SHEATH AND ICE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED. TRANSSEPTAL PUNCTURE PERFORMED WITH BAYLIS VERSACROSS WIRE AND SHEATH, BOSTON SCIENTIFIC, REF VXAK0007. THEY PLACED A DRAIN, USED A CELL SAVER TO RESTORE SOME OF THE BLOOD AND THEN REMOVED THE DRAIN THE FOLLOWING DAY. THE PATIENT FULLY RECOVERED AND SENT HOME NEXT DAY. THE ADVERSE EVENT WAS NOTICED SHORTLY AFTER ABLATION STARTED, BUT EFFUSION WAS NOT CHECKED FOR AFTER TRANSSEPTAL AND CS WAS MOVED IN RIGHT VENTRICLE (RV) AFTER ABLATION BEGAN. PHYSICIAN BELIEVES THE CAUSE OF THE EVENT WAS PROCEDURAL RELATED, THE EXACT CAUSE WAS UNKNOWN BUT DUE TO LOCATION OF OBSERVED EFFUSION, HE BELIEVES IT MAY HAVE BEEN DUE TO THE CS CATHETER PLACED IN THE RV, OR THE TRANSSEPTAL NEEDLE. CORRECT SETTINGS USED ON DEVICES AND NO ERROR MESSAGES ON EQUIPMENT. SHE HAD AN ASD PATCH PRIOR TO THIS PROCEDURE, BUT THE PHYSICIAN DOES NOT BELIEVE THIS TO BE RELEVANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169387 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| R BAYLIS VERSACROSS WIRE SHEATH, BOSTON SCIENTIFIC| SMARTABLATE GENERATOR KIT-US| UNK PUMP| UNK_CARTO 3| UNK_CS CATHETER| UNK_ICE CATHETER| UNK_VIZIGO SHEATH