BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19515727 · Received June 11, 2024

    Report

    Report Number
    2029046-2024-01911
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 5, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 12-JUN-2024. IT WAS REPORTED THAT THE PATIENT'S CONDITION IMPROVED AND FULLY RECOVERED. 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 · 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. 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 BI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER AN ATRIAL FIBRILLATION PROCEDURE, WHILE THE PATIENT WAS IN RECOVERY, THEIR BLOOD PRESSURE DROPPED. A TRANSTHORACIC ECHO WAS PERFORMED, AND A PERICARDIAL EFFUSION WAS DISCOVERED. THE PATIENT WAS BROUGHT BACK IN THE LAB, AND A PERICARDIOCENTESIS WAS PERFORMED WHERE 550ML OF FLUID WAS REMOVED, AND 250 ML OF FLUID WAS GIVEN BACK. THE PATIENT¿S BLOOD PRESSURE WENT BACK TO NORMAL, AND THE PATIENT NO LONGER FELT NAUSEOUS. THE PATIENT WAS THEN TAKEN BACK TO RECOVERY. THIS WAS THE FIRST PROCEDURE OF THE DAY. THE CATHETERS ARE NOT AVAILABLE FOR RETURN AS THEY HAVE BEEN DISCARDED. THE PHYSICIAN PERFORMED PULSED FIELD ABLATION (PFA) WITH FARAPULSE¿ ON THE RIGHT ATRIUM, AND RIGHT ATRIAL FLUTTER LINE WITH FARAPULSE¿. THEY COULD NOT GET BLOCK AND THE LINE WAS FINISHED WITH STSF USING A NGEN SYSTEM. THE PHYSICIAN STATED THAT THIS WAS A RIGHT SIDED EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368569 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R BOSTON SCIENTIFIC FARAPULSE¿ CATHETER| UNK_NGEN RF GENERATOR