BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24912408 · Received April 17, 2026

    Report

    Report Number
    2029046-2026-01260
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 17, 2026
    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. THE DEVICE EVALUATION DETAILS. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 17-MAR-2026. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, TEMPERATURE, AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE WAS CONNECTED TO THE GENERATOR. TEMPERATURE AND IMPEDANCE TESTING WERE PERFORMED; HOWEVER, NEITHER TEMPERATURE NOR IMPEDANCE VALUES WERE DISPLAYED. DUE TO THE ISSUE OBSERVED AT THE GENERATOR, A DISSECTION WAS CONDUCTED. DURING DISSECTION, AN OPEN CIRCUIT WAS IDENTIFIED NEAR THE CONNECTOR AREA, WHICH CAUSED THE TEMPERATURE FAULT, AND AN ADDITIONAL OPEN CIRCUIT WAS FOUND AT THE TIP SECTION, RESULTING IN THE IMPEDANCE FAULT. ADDITIONALLY, THE PULLER WIRE WAS FOUND TO BE BROKEN NEAR THE DISTAL TIP OF THE DEVICE. FINALLY, A HOLE WAS IDENTIFIED IN THE PEBAX OUTER SURFACE DURING DISSECTION, WITH NO VISIBLE FOREIGN MATERIAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IMPEDANCE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUITS AND THE BROKEN PULLER WIRE COULD NOT BE DETERMINED. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE PEBAX DAMAGE, TEMPERATURE ISSUE, AND BROKEN PULLER WIRE ARE UNRELATED TO THE ISSUE REPORTED BY THE CUSTOMER. IN RELATION TO THE IMPEDANCE ISSUE, THE NGEN GENERATOR USER MANUAL CONTAINS THE FOLLOWING INFORMATION: DO NOT USE TEMPERATURE SETTINGS HIGHER THAN THOSE RECOMMENDED IN THE INSTRUCTIONS FOR USE FOR THE CATHETERS. WHEN AN IRRIGATED CATHETER IS USED, THE TEMPERATURE MEASUREMENT REFLECTS THE TEMPERATURE OF THE COOLED IRRIGATED ELECTRODE, NOT THE TEMPERATURE OF THE TISSUE. THE TEMPERATURE OF THE TISSUE MAY BE DISTINCTLY HIGHER AND THE RISK OF STEAM POP MAY INCREASE. REGARDING THE PEBAX DAMAGE, THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: 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. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: SEPARATION PROBLEM (C070603) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: STEERING WIRE (G04121) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿PULLER WIRE BROKEN NEAR THE DISTAL TIP OF THE DEVICE¿. INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRICAL LEAD/WIRE (G02015) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿OPEN CIRCUIT NEAR THE CONNECTOR AREA¿. INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRICAL LEAD/WIRE (G02015) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿UNSTABLE IMPEDANCE¿ ISSUE. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿OPEN CIRCUIT WAS FOUND AT THE TIP SECTION¿. INVESTIGATION FINDINGS: MATERIAL AND/OR CHEMICAL PROBLEM IDENTIFIED (C06) / INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF A ¿HOLE WAS IDENTIFIED IN THE PEBAX¿. 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 HOLE IN THE PEBAX. UNSTABLE IMPEDANCE. DURING THE PROCEDURE, THE IMPEDANCE DISPLAYED CHANGED A LOT IN ONE MOMENT. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE IMPEDANCE CUT-OFF VALUE EXCEEDED; HOWEVER, THE SYSTEM STOPPED THE ABLATION IMMEDIATELY WHEN THIS OCCURRED. GENERATOR PARAMETERS WERE POWER CONTROL MODE AND POWER CUT OFF WAS 40W. NOTED IMPEDANCE WAS 90-170O. ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED IT WAS AN UNSTABLE IMPEDANCE ISSUE. IMPEDANCE FLUCTUATED FROM 90O TO 170O AND ABOVE THE HIGHEST THRESHOLD. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 24-MAR-2026, A HOLE WAS IDENTIFIED IN THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE PEBAX ON 24-MAR-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578575 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31728254L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown