BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 23885316 · Received December 23, 2025

    Report

    Report Number
    2029046-2025-04286
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 23, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND A DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. A DEFLECTION TEST WAS PERFORMED, AND THE DEVICE WAS DEFLECTING WITHIN SPECIFICATIONS. NO DEFLECTION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE REDDISH MATERIAL INSIDE THE PEBAX WAS NOT ORIGINALLY REPORTED AND IT IS UNRELATED TO THE CUSTOMER EVENT. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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. THE DEFLECTION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT MAY HAVE AFFECTED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN 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. AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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), PAROXYSMAL ABLATION PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL SF (STSF) AND DURING THE OPERATION, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. THEY REPLACED THE CATHETER WITH ANOTHER ONE TO CONTINUE THE SURGERY. 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 (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND A DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830367 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31658380L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown