BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23648571 · Received November 25, 2025

    Report

    Report Number
    2029046-2025-03912
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. 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

    DURING IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) PROCEDURE, AFTER ABLATING WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION (DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY) TREATED WITH PERICARDIOCENTESIS. THE PATIENT WAS IN STABLE CONDITION EVEN AS THE EFFUSION WAS STILL PRESENT, BUT THE MEDICAL TEAM ELECTED TO NOT DRAIN ANY MORE BLOOD. THE FOLLOWING J&J MEDTECH ELECTROPHYSIOLOGY PRODUCTS WERE IN USE CARTO VIZIGO BI-DIRECTIONAL GUIDING SHEATH LARGE CURVE, THERMOCOOL SMARTTOUCH SF D-F ABLATION CATHETER, 8F SOUNDSTAR ULTRASOUND CATHETER, OPTRELL 36 MAPPING CATHETER, NGEN GENERATOR, AND CARTO 3 SYSTEM. THE PRODUCTS WERE DISCARDED AND NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947805 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L 8F SOUNDSTAR® ULTRASOUND CATHETER| CARTO 3 SYSTEM| CARTO VIZIGO® BI-DIRECTIONAL GUIDING SHEATH| NGEN¿ GENERATOR| OPTRELL¿ 36 MAPPING CATHETER