BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8584144 · Received May 6, 2019

    Report

    Report Number
    2029046-2019-03069
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835000566
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A PACING PROBLEM AFFECTED EMERGENCY PACING. IT WAS INITIALLY REPORTED THAT THEY WERE UNABLE TO PACE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 8, 2019 ON THE EVENT. THE PACING LEADS WERE CONNECTED TO THE PRIMARY PACING PORT. THE EP4 PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. THERE WAS NO UNWANTED PACING BEING DELIVERED. THE PACING PROBLEM AFFECTED BOTH ROUTINE AND EMERGENCY PACING. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THEN, AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. THEN, AN IRRIGATION TEST WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING CORRECTLY, NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30090961M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 5/3/2019. 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. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A PACING PROBLEM AFFECTED EMERGENCY PACING. IT WAS INITIALLY REPORTED THAT THEY WERE UNABLE TO PACE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE PACING ISSUE DESCRIBED WAS ASSESSED AS NOT REPORTABLE. THE CATHETER WOULD NEED TO BE REPLACED SINCE IT WAS NOT ABLE TO PACE FOR STIMULATION. THERE WOULD BE NO RISK TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 8, 2019 ON THE EVENT. THE PACING LEADS WERE CONNECTED TO THE PRIMARY PACING PORT. THE EP4 PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. THERE WAS NO UNWANTED PACING BEING DELIVERED. THE PACING PROBLEM AFFECTED BOTH ROUTINE AND EMERGENCY PACING. THERE WAS NO PATIENT CONSEQUENCE REPORTED. BASED ON THE ADDITIONAL INFORMATION STATING THAT THE PACING PROBLEM ALSO AFFECTED EMERGENCY PACING, THIS PACING ISSUE HAS BEEN RE-ASSESSED TO MDR REPORTABLE. THE AWARENESS DATE IS APRIL 8, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377027 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 30090961M 10846835000566

    Patients

    Seq Age Sex Outcome Treatment
    1