BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2103237 · Received May 25, 2011

    Report

    Report Number
    9673241-2011-00055
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IN THIS COMPLAINT WAS RELATED TO A WHITISH SUBSTANCE RESEMBLING FIBRIN NOTED ON THE CATHETER TIP AFTER A RIGHT-SIDED ATRIAL FLUTTER PROCEDURE. UPON RECEIPT OF THE RETURNED DEVICE, VISUAL INSPECTION EXHIBITED FOREIGN MATERIAL ON THE CATHETER TIP. THE DEVICE WAS TESTED FOR ELECTRICAL PERFORMANCE, STOCKERT COMPATIBILITY, THERMAL SENSOR RESPONSE AND PATENCY FLOW TESTS. THE ELECTRICAL RESISTANCE AND LEAKAGE TESTS WERE FOUND WITHIN SPECIFICATIONS. THE THERMOCOUPLE SENSOR PASSED WHEN IMMERSED IN FLUID WITH CONTROLLED TEMPERATURE. THE CATHETER INTERFACED WITH THE STOCKERT OBTAINING ACCEPTABLE ABLATION READINGS. HOWEVER, THE PATENCY FLOW TEST FAILED. THE CATHETER WAS NOT IRRIGATING WHEN TESTED. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBING WAS OBSTRUCTED WITH SOME BROWNISH MATERIAL NOT ALLOWING FLUID TO FLOW THROUGH. THE BROWNISH RESIDUE/ MATERIAL WAS NOT PART OF THE COMPLAINT INITIALLY REPORTED. BOTH THE WHITISH AND BROWNISH MATERIALS FOUND WERE ANALYZED USING THE FT-IR METHOD FOR MATERIAL IDENTIFICATION. THE FT-IR RESULTS SHOWED THAT BOTH MATERIALS CONSISTED OF PROTEIN THAT CAN BE FOUND IN THE AORTIC AND/OR VEIN TISSUES. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, DHR REVIEW VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CONDITION WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AS INITIALLY REPORTED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A RIGHT-SIDED ATRIAL FLUTTER PROCEDURE, UPON RETRIEVAL, THE CATHETER APPEARED TO BE WRAPPED BY A WHITISH SUBSTANCE RESEMBLING FIBRIN. THE SURGEON TRIED TO REMOVE THE SUBSTANCE, HOWEVER IT REMAINED STUCK ON THE CATHETER TIP. IT WAS MENTIONED THAT THERE WAS NO SHARP EDGES ON THE CATHETER TIP. THE PHYSICIAN ENCOUNTERED SOME DIFFICULTIES IN ABLATING AND BLOCKING THE RIGHT ISTHMUS. HE ALSO HAD OTHER UNSPECIFIED DIFFICULTIES AFTER HAVING CHANGED THE CATHETER. IT WAS STATED THAT THIS MAY BE DUE TO UNCOMMON PATIENT ANATOMY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO MEDICAL INTERVENTION PERFORMED. THE PROCEDURE WAS COMPLETED BY USING A NEW CATHETER WITHOUT ANY PROBLEM. THE USERS WERE UNSURE IF THEY CHECKED THE CATHETER TIP BEFORE INSERTING IT TO THE PATIENT AS RECOMMENDED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15302545M

    Patients

    Seq Age Sex Outcome Treatment
    1