BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSIUS¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 18957051 · Received March 22, 2024

    Report

    Report Number
    2029046-2024-00979
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Report Date
    April 19, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835000405
    PMA / PMN Number
    P950005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND WHEN OPENING THE PACKAGE, UPON VISUAL INSPECTION, THE CATHETER APPEARED DEFECTIVE ON THE CATHETER TIP, JUST BELOW PROXIMAL ELECTRODES. THERE WAS A BEND AT THE DISTAL PORTION AND BRAIDING EXPOSED. THE CATHETER WAS NOT INSERTED IN PATIENT. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND TILT TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. NO EXPOSED WIRES WERE OBSERVED. THE DEVICE TIP WAS REVIEWED, AND IT WAS FOUND WITHIN SPECIFICATIONS. NO BENT PARTS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 30936993M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE EXPOSED PARTS AND BENT TIP ISSUES REPORTED BY THE CUSTOMER WERE NOT CONFIRMED SINCE NO DAMAGE WAS OBSERVED. THE CUSTOMER COULD BE REPORTING THE ANCHOR WINDOW THAT IS PART OF THE CATHETER DESIGN AND IT¿S FILLED WITH ADHESIVE COVERING THE INTERNAL COMPONENTS. NO MANUFACTURING ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S 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 CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND WHEN OPENING THE PACKAGE, UPON VISUAL INSPECTION, THE CATHETER APPEARED DEFECTIVE ON THE CATHETER TIP, JUST BELOW PROXIMAL ELECTRODES. THERE WAS A BEND AT THE DISTAL PORTION AND BRAIDING EXPOSED. THE CATHETER WAS NOT INSERTED IN PATIENT. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555964 CELSIUS¿ ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 30936993M 10846835000405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown