BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 23019573 · Received September 10, 2025

    Report

    Report Number
    2029046-2025-03087
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    July 16, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009514
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SMART TOUCH UNIDIRECTIONAL DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION AND DEFLECTION TEST WERE PERFORMED FOLLOWING J&J PROCEDURES. A VISUAL INSPECTION WAS PERFORMED, AND THE ELECTRODE WAS FOUND DETACHED FROM THE TIP, LEAVING INTERNAL PARTS EXPOSED, HOWEVER, APPLICATION OF ADHESIVE WAS OBSERVED ON THE TIP, WHICH INDICATES THE DEVICE WAS MANUFACTURED CORRECTLY. THE SHAFT WAS ALSO FOUND BENT. DEFLECTION TEST WAS PERFORMED AND THE PULLER WIRE WAS FOUND BROKEN IN THE SHAFT BENT ZONE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE BROKEN PULLER WIRE COULD BE RELATED TO THE DEFLECTION ISSUE REPORTED BY THE CUSTOMER; THEREFORE THE COMPLAINT WAS CONFIRMED. HOWEVER, SHAFT BENT AND ELECTRODE DETACHED ARE UNRELATED TO THE REPORTED EVENT. THE POTENTIAL CAUSE OF THE ELECTRODE DETACHED, SHAFT BENT, AND PULLER WIRE BROKEN CANNOT BE DETERMINED. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE SYNDROME ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND DURING THE OPERATION, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH AND THE ELECTRODE WAS FOUND DETACHED FROM THE TIP, LEAVING INTERNAL PARTS EXPOSED. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778354 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31615298M 10846835009514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown