BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 23846889 · Received December 18, 2025

    Report

    Report Number
    2029046-2025-04232
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    September 17, 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

    DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON AND JOHNSON MEDTECH FOR EVALUATION. JOHNSON AND JOHNSON MEDTECH CONDUCTED A VISUAL INSPECTION AND DEFLECTION EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION FOUND REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. DEFLECTION TESTING WAS PERFORMED AND OBSERVED THAT THE TIP DEFLECTS PROPERLY. 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 COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION, HOWEVER, THE DAMAGE OBSERVED IS NOT RELATED TO THE REPORTED EVENT. THE POTENTIAL CAUSE OF THE DAMAGE ON THE PEBAX COULD BE RELATED TO THE USAGE OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. CONCERNING THE PEBAX DAMAGE, THE CATHETER INSTRUCTION FOR USE (IFU) RECOMMENDED: 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. AS PART OF JOHNSON AND JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE HOLE IN THE PEBAX IDENTIFIED BY BWI PAL. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED DEFLECTION ISSUE. NOTE: 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 UNIDIRECTIONAL SF APPROVED UNDER P030031/S078. 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. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED DEFLECTION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 27-NOV-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257311 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31620908L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown