BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TOUCH UNIDIRECTIONAL

    MDR report key: 23247816 · Received October 8, 2025

    Report

    Report Number
    2029046-2025-03399
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    August 3, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    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 DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. VISUAL ANALYSIS REVEALED A LIFTED ELECTRODE AND REDDISH MATERIAL PRESUMABLY BLOOD IN THE PEBAX. FURTHER INVESTIGATION REVEALED A CUT IN THE PEBAX IN THE LIFTED ELECTRODE AREA. NO MANUFACTURING ASSEMBLY ISSUES WERE OBSERVED AROUND THE DAMAGED ELECTRODE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ELECTRODE DAMAGE AND PEBAX CONDITION COULD BE RELATED TO EXCESSIVE FORCE OR THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE CATHETER 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. 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'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 SMART TOUCH UNI DIRECTIONAL 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A LIFTED ELECTRODE AND REDDISH MATERIAL PRESUMABLY BLOOD IN THE PEBAX. INITIALLY, IT WAS REPORTED THAT DURING THE OPERATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER TIP. THERE WERE NO DEFINITE PHYSICAL BREAKS OR CRACKS THAT APPEAR TO BE IDENTIFIED. A NEW CATHETER WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORT. WITH THE INITIAL INFORMATION PROVIDED, THE EVENT WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT IS LOW. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 12-SEP-2025, THAT THERE WAS LIFTED ELECTRODE AND REDDISH MATERIAL PRESUMABLY BLOOD IN THE PEBAX. FURTHER INVESTIGATION REVEALED A CUT IN THE PEBAX IN THE LIFTED ELECTRODE AREA. THE CUT IN THE PEBAX AND LIFTED ELECTRODE WERE ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 12-SEP-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584319 SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31651492M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown