BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 25250809 · Received May 21, 2026

    Report

    Report Number
    2029046-2026-01652
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 24, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31782720L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. DURING THE LEFT ATRIAL GEOMETRY ACQUISITION, THE ABLATION CATHETER DISENGAGED FROM THE LEFT ATRIUM. WHILE REINSERTING THE CATHETER THROUGH THE BROCKENBROUGH HOLE (TRANSSEPTAL PUNCTURE SITE), THE CONTACT FORCE BRIEFLY REACHED 50G (THE CATHETER WAS PUSHED TOO HARD). AFTER SOME TIME, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE OCCURRED. AFTER DRAINAGE, BLOOD PRESSURE RETURNED TO NORMAL AND CONSCIOUSNESS RECOVERED. PATIENT FULLY RECOVERED. PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. AFTER MAPPING, THE ABLATION CATHETER CAME OUT OF THE LEFT ATRIUM. EXCESSIVE FORCE WAS APPLIED TO THE CATHETER DURING REINSERTION THROUGH THE TRANSSEPTAL PUNCTURE SITE. THERE WAS NO MALFUNCTION WITH THE CATHETER ITSELF. NO ERROR CODE WAS DISPLAYED. NO ABLATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77170 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31782720L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| L