BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23861357 · Received December 21, 2025

    Report

    Report Number
    2029046-2025-04251
    Event Type
    Malfunction
    Date Received
    December 21, 2025
    Date of Event
    October 20, 2025
    Report Date
    December 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009804
    PMA / PMN Number
    P030031/S078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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 SF APPROVED UNDER P030031/S078. INVESTIGATION COMPLETION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 18-NOV-2025. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED. FOREIGN MATERIAL WAS OBSERVED IN THE PEBAX IN THE PICTURE PROVIDED BY THE CUSTOMER. DURING THE VISUAL INSPECTION, REDDISH BROWN MATERIAL WAS ALSO FOUND INSIDE THE PEBAX AND A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION. DEFLECTION TESTING WAS PERFORMED, AND THE DEFLECTION MECHANISM FAILED SPECIFICATIONS DUE TO THE PULLER WIRE WAS FOUND BROKEN AT THE TIP AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE DEFLECTION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED, AND THE FOREIGN MATERIAL SHOWN IN THE PICTURE PROVIDED BY THE CUSTOMER WAS ALSO CONFIRMED. THE ROOT CAUSE OF THE PEBAX DAMAGE IS TRACED TO THE MANUFACTURING PROCESS. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING INFORMATION: THE CATHETER TIP CAN BE DEFLECTED TO FACILITATE POSITIONING BY USING THE THUMB KNOB TO VARY TIP CURVATURE. PUSHING THE THUMB KNOB FORWARD CAUSES THE CATHETER TIP TO DEFLECT; WHEN THE THUMB KNOB IS PULLED BACK, THE TIP STRAIGHTENS. 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. A SIGNIFICANT CHANGE IN THE BASELINE READING AFTER CLEANING MIGHT INDICATE A DAMAGED CONTACT FORCE SENSOR. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, VERIFY COMPATIBILITY BETWEEN THE SHEATH AND CATHETER, ADVANCE THE CATHETER THROUGH THE SHEATH PRIOR TO INSERTION. ANY SHEATH < 8.5 F IS CONTRAINDICATED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE FORCE SENSOR SLEEVE INSOLATION TO PREVENT FLUIDS TO GET INSIDE INTO THE DEVICE. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MANUFACTURING PROCESS PROBLEM IDENTIFIED (C16) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿FOREIGN MATERIAL IN THE PEBAX IN THE PICTURE¿ ISSUE. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿MANUFACTURING PROCESS¿ RELATED. INVESTIGATION FINDINGS: SEPARATION PROBLEM (C070603) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: STEERING WIRE (G04121) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿DEFLECTION ISSUE¿ ISSUE. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿PULLER WIRE WAS FOUND BROKEN AT THE TIP AREA¿. INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿FOREIGN MATERIAL IN THE PEBAX IN THE PICTURE¿ ISSUE. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION¿. 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 A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. A PICTURE WAS PROVIDED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 25-NOV-2025, OBSERVED REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION ON 25-NOV-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205368 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31658213L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown