BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 24614889 · Received March 17, 2026

    Report

    Report Number
    2029046-2026-00880
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 16, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31824514M AND NO INTERNAL ACTIONS 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, THE PATIENT EXPERIENCED AV BLOCK TREATED WITH PERMANENT PACEMAKER PLACEMENT. THE REPORT INDICATED THAT AFTER ONE ABLATION WITH PULSED FIELD ABLATION (PFA) (SMARTTOUCH + CARDIOFOCUS PFA GENERATOR) FAR FROM THE GUIDANCE SYSTEM, AN AV BLOCK IS FORMED. IT IS POSSIBLE THAT THE PULSE (PARTIALLY) WAS EMITTED BY THE PROXIMAL SHAFT ELECTRODES OF THE ABLATION CATHETER. THESE SHAFT ELECTRODES WERE PROBABLY LOCATED NEAR THE GUIDANCE SYSTEM IN THE LEFT VENTRICLE (LV) SEPTUM. THE EVENT OCCURRED FOLLOWING RETROGRADE LV ACCESS WITH THERMOCOOL SMARTTOUCH ABLATION CATHETER FOR A PVC PROCEDURE. A PERMANENT PACEMAKER WAS PLACED IMMEDIATELY AFTER DETECTION OF AV BLOCK. ALTHOUGH IT IS POSSIBLE THAT THE AV BLOCK WILL RECOVER AFTER AN HOUR, THE HOSPITAL DECIDED TO PLACE A PACEMAKER IMMEDIATELY. THE PATIENT WAS STABLE AND DID NOT REQUIRE EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95077 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31824514M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1