BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 18240548 · Received November 30, 2023

    Report

    Report Number
    2029046-2023-02792
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    January 1, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835000566
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 15-DEC-2023, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31116362M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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

    E1 INITIAL REPORTER CITY: (B)(6). 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-(B)(4).

    Additional Manufacturer Narrative · 0

    ON 11-JAN-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND BLOOD RAN BACK INTO THE IRRIGATION SUPPLY LINE. THE MEDICAL TEAM BELIEVED THAT THERE WAS PRESSURE BUILT UP WITHIN THE SUPPLY LINE, SO MUCH SO THAT THE IRRIGATION TUBE CAME OFF. ACCORDING TO THE NURSING STAFF, THE ABLATION CATHETER WAS FLUSHED BEFOREHAND AND EVERYTHING WAS WITHIN THEIR EXPECTED STANDARD. THE PUMP WAS PROBABLY ALSO RUNNING WHILE THE CATHETER WAS IN THE PATIENT. THE PHYSICIAN THEN NOTICED THE ISSUE WHEN THEY STARTED TO ABLATE. THE PHYSICIAN SAW BLOOD RUNNING INTO THE CATHETER. THE CATHETER COULD NO LONGER BE FLUSHED THROUGH. IT IS UNKNOWN IF THE NURSE STAFF USED HEPARIN FOR THE IRRIGATION SOLUTION OR IF THEY USED HEPARIN IN GENERAL, BUT THE PROCEDURE WAS PERFORMED IN THE LEFT ATRIUM. SO, ACCORDING TO STANDARD GUIDELINES, HEPARIN SHOULD HAVE BEEN USED. ADDITIONALLY, A BWI GENERATOR WAS NOT USED IN THIS PROCEDURE--A COMPETITOR'S GENERATOR AND PUMP WERE USED INSTEAD, THEREFORE, IT CANNOT BE CONFIRMED IF THE PROPER SETTINGS WERE USED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND PUMP AND PRESSURE GAGE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A PUMP AND PRESSURE GAGE TEST WAS PERFORMED AND THE DEVICE WAS FOUND OCCLUDED. FURTHER INVESTIGATION REVEALED REDDISH MATERIAL BLOCKING THE LUER HUB AND IRRIGATION HOLES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31116362M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE REDDISH MATERIAL OBSERVED IN THE LUER HUB AND DOME COULD BE RELATED TO THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 AN UNSPECIFIED CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND BLOOD RAN BACK INTO THE IRRIGATION SUPPLY LINE. THE MEDICAL TEAM BELIEVED THAT THERE WAS PRESSURE BUILT UP WITHIN THE SUPPLY LINE, SO MUCH SO THAT THE IRRIGATION TUBE CAME OFF. ACCORDING TO THE NURSING STAFF, THE ABLATION CATHETER WAS FLUSHED BEFOREHAND AND EVERYTHING WAS WITHIN THEIR EXPECTED STANDARD. THE PUMP WAS PROBABLY ALSO RUNNING WHILE THE CATHETER WAS IN THE PATIENT. THE PHYSICIAN THEN NOTICED THE ISSUE WHEN THEY STARTED TO ABLATE. THE PHYSICIAN SAW BLOOD RUNNING INTO THE CATHETER. THE CATHETER COULD NO LONGER BE FLUSHED THROUGH. IT IS UNKNOWN IF THE NURSE STAFF USED HAPARIN FOR THE IRRIGATION SOLUTION OR IF THEY USED HEPARIN IN GENERAL, BUT THE PROCEDURE WAS PERFORMED IN THE LEFT ATRIUM. SO, ACCORDING TO STANDARD GUIDELINES, HEPARIN SHOULD HAVE BEEN USED. ADDITIONALLY, A BWI GENERATOR WAS NOT USED IN THIS PROCEDURE--A COMPETITOR'S GENERATOR AND PUMP WERE USED INSTEAD, THEREFORE, IT CANNOT BE CONFIRMED IF THE PROPER SETTINGS WERE USED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771312 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 31116362M 10846835000566

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown