BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 24931558 · Received April 20, 2026

    Report

    Report Number
    2029046-2026-01286
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 20, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009507
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED REDDISH MATERIAL, PRESUMABLY BLOOD INSIDE THE PEBAX AND A SEPARATION BETWEEN ELECTRODE AND PEBAX. ADDITIONALLY, THE SHAFT WAS BENT. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS FLUSHING CORRECTLY. NO IRRIGATION ISSUES WERE OBSERVED. THE BLOOD LEAKAGE ISSUE DESCRIBED COULD BE RELATED TO THE PEBAX DAMAGE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE ON PEBAX IS RELATED TO THE MANUFACTURING PROCESS OF THE DEVICE. THE POTENTIAL CAUSE OF THE BENT SHAFT COULD BE RELATED TO THE HANDLING/SHIPPING AFTER THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE STATES: WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT; TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE OR MAY DAMAGE THE CONTACT FORCE SENSOR. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATION. INTERNAL CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO ADDRESS MANUFACTURING OPPORTUNITIES RELATED TO THE FORCE SENSOR SLEEVE INSOLATION TO PREVENT FLUIDS FROM GETTING INSIDE INTO THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND DURING THE OPERATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. THE BLOOD LEAKAGE WAS NOTICED ON THE TIP OF THE CATHETER, INSIDE THE INFUSION HOLE. THERE WAS NO PART OF THE CATHETER THAT WAS NOTICED AS PHYSICALLY BROKEN. A NEW CATHETER WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORTED. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WAS PERFORMED. VISUAL ANALYSIS REVEALED REDDISH MATERIAL, PRESUMABLY BLOOD INSIDE THE PEBAX AND A SEPARATION BETWEEN ELECTRODE AND PEBAX. ADDITIONALLY, THE SHAFT WAS BENT. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88778 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31750435M 10846835009507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown