BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3890040 · Received June 24, 2014

    Report

    Report Number
    9673241-2014-00232
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERFORATION DURING THE PROCEDURE. THE CALLER STATED THAT THEY WERE ABLATING IN THE RV WHEN THEY GOT A STEAM POP WHILE ABLATING AT 40 WATTS. THE PATIENT¿S PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT¿S PRESSURE WAS HIGHER AND STABLE THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3 AND COIL DISCONNECTION TESTER. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE SENSOR COILS RESISTANCE WAS FOUND WITHIN SPECIFICATIONS. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERFORATION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4)

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA - RIGHT (R-IDVT) PROCEDURE WITH AN EZ STEER THERMOCOOL NAV 4MM AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. IT WAS STATED THAT THE CUSTOMER WAS ABLATING IN THE RIGHT VENTRICLE WHEN THEY GOT A STEAM POP WHILE ABLATING AT 40 WATTS. THE PATIENT¿S PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT¿S PRESSURE WAS HIGHER AND STABLE. THE ABLATION PROCEDURE WAS STOPPED. IT WAS STATED THAT THE PATIENT IS STABLE. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THE PROCEDURE. HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369190 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15997192M

    Patients

    Seq Age Sex Outcome Treatment
    1