BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 21997857 · Received May 9, 2025

    Report

    Report Number
    2029046-2025-01502
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009989
    PMA / PMN Number
    K080425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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).

    Additional Manufacturer Narrative · 0

    ON 17-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE CATHETER HAD A BROKEN TIP/SHAFT. THE DEVICE WAS DISCOVERED TO BE BROKEN BEFORE USAGE IN THE PATIENT. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED THAT THE TIP OF THE DEVICE WAS TOTALLY SEPARATED, AND PRESUMABLY INSUFFICIENT ADHESIVE WAS DETECTED. DUE TO THIS CONDITION, A MANUFACTURING INVESTIGATION WAS INITIATED; AFTER PHYSICAL VERIFICATION OF THE DEFECTIVE UNIT UNDER MICROSCOPE, RESIDUES OF POLYURETHANE (PU) WERE OBSERVED INDICATING A CORRECT APPLICATION ALONG TIP TREPAN AND SHAFT INCLUDING ITS TRANSITION DESPITE THAT THE CATHETER WAS RECEIVED WITH THE TIP COMPLETELY DETACHED FROM SHAFT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31577554M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. EVEN THOUGH THE ISSUE WAS NOT DEEMED TO BE MANUFACTURING RELATED, AN AWARENESS SESSION WAS COMPLETED TO REINFORCE THE IMPORTANCE OF PU APPLICATION AND ACCEPTANCE CRITERIA. IN ACCORDANCE WITH THE PROCESS FAILURE MODE AND EFFECTS (PFMEA) CATHETER WITH POTENTIAL PROCESS FAILURE MODE OF HAVING LOOSE TIP TO SHAFT, THIS FAILURE MODE COULD LEAD TO PRODUCT DETACHMENT INSIDE THE PATIENT CLASSIFIED AS HIGH RISK; THEREFORE, A NON-CONFORMANCE WAS OPENED TO FURTHER INVESTIGATE THIS ISOLATED CASE. AFTER PHYSICAL VERIFICATION OF THE DEFECTIVE UNIT AND AFTER ATTEMPTS TO REPLICATE FAILURE. A CONCLUSIVE ROOT CAUSE FOR THE FAILURE ANALYSIS OF THE DEFECTIVE PIECE COULD NOT BE DETERMINED GIVEN THAT THE MENTIONED PIECE PRESENTED EVIDENT SIGNS OF EXTERNAL MANIPULATION OR EXCESSIVE FORCE APPLIED. THE BROKEN TIP ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DETACHMENT COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AN INTERNAL ACTION WAS CREATED TO FURTHER INVESTIGATE THE TIP DETACHMENT ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 7-AUG-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE CATHETER HAD A BROKEN TIP/SHAFT. THE DEVICE WAS DISCOVERED TO BE BROKEN BEFORE USAGE IN THE PATIENT. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED THAT THE TIP OF THE DEVICE WAS TOTALLY SEPARATED AND PRESUMABLY INSUFFICIENT ADHESIVE WAS DETECTED. DUE TO THIS CONDITION, A MANUFACTURING INVESTIGATION WAS REQUESTED AND IT WAS CONCLUDED THAT THIS TYPE OF FAILURE WAS RELATED TO THE MANUFACTURING PROCESS AS INSUFFICIENT ADHESIVE WAS IDENTIFIED BETWEEN THE TIP AND SHAFT TRANSITION. ADHESIVE WAS NOT APPLIED IN ACCORDANCE WITH THE PROCESS INSTRUCTIONS, THIS EVENT WAS CONSIDERED AS A MAN ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31577554M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE BROKEN TIP ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE OF THIS FAILURE WAS RELATED TO THE MANUFACTURING PROCESS. A NON CONFORMANCE WAS OPENED TO ADDRESS INVESTIGATION AND CORRECTION ACTIONS RELATED TO THIS FAILURE. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE CATHETER HAD A BROKEN TIP/SHAFT. THE DEVICE WAS DISCOVERED TO BE BROKEN BEFORE USAGE IN THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217520 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31577554M 10846835009989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown