BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 24016586 · Received January 8, 2026

    Report

    Report Number
    2029046-2026-00079
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    November 5, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009811
    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 DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A HOLE AND REDDISH MATERIAL INSIDE THE PEBAX. THE DEVICE WAS CONNECTED TO CARTO 3 SYSTEM, AND IT WAS RECOGNIZED; HOWEVER, ERROR 105 AND 106 APPEARED ON THE SYSTEM DUE TO AN OPEN CIRCUIT IN THE TIP AREA. THE ADHESIVE IN THE TIP AREA WAS INSPECTED AN IT WAS OBSERVED WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE FORCE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE HOLE IN THE PEBAX IS NOT RELATED TO THE ISSUE REPORTED BY THE CUSTOMER. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT COULD NOT BE DETERMINED. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE CARTO® 3 SYSTEM INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. 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: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SENSOR (G03012) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED FORCE ISSUES. 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, THE FORCE VALUES DISPLAYED WERE HIGH. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED FORCE 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 17-DEC-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
    77158 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31661965L 10846835009811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown