BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 25088950 · Received May 5, 2026

    Report

    Report Number
    2029046-2026-01462
    Event Type
    Injury
    Date Received
    May 5, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH APPROVED UNDER P030031/S053. 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 A PULMONARY VEIN ISOLATION (PVI) ABLATION WITH A THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. PHYSICIAN PERFORMED TRANSSEPTAL (TSP) WITHOUT DIFFICULTIES. PHYSICIAN MAPPED THE LEFT ATRIUM (LA) WITH THE PENTARAY CATHETER. PHYSICIAN ABLATED THE PULMONARY VEINS (PV) WITH THERMOCOOL SMARTTOUCH CATHETER WITHOUT DIFFICULTIES. CASE ENDED. DURING THE RUTINARY ECHOCARDIOGRAM AT THE END OF THE CASE, PHYSICIAN NOTED A PERICARDIAL EFFUSION WITH APPROXIMATELY 600ML OF BLOOD IN PERICARDIUM. PHYSICIAN PERFORMED A PERICARDIOCENTESIS. AFTER ONE DAY, PHYSICIAN INFORMED THAT PATIENT WAS STABLE AND RECOVERED. AFTER THE CASE, PHYSICIAN EXPRESSED THAT HE THINKS THE EFFUSION HAPPENED DURING ABLATION IN THE LA, BUT IT WAS NOT NOTICED DURING THE CASE THROUGH A DECREASE OF BLOOD PRESSURE BECAUSE IN SOME PATIENTS WITH OTHER DISEASES, THE HEART CAN COMPENSATE TO AN EXTENT. DURING THE CASE, A STEEP INCREASE OR DECREASE OF IMPEDANCE DURING ABLATION WAS NOT NOTICED. IN ONE ABLATION POINT IN THE LEFT SUPERIOR PULMONARY VEIN A QUICK RISE OF FORCE WAS NOTICED AND THE ABLATION WAS STOPPED IMMEDIATELY. THE DURATION OF THE HIGH FORCE WAS LESS THAN A SECOND. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123388 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1