BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2858358 · Received December 5, 2012

    Report

    Report Number
    9673241-2012-00351
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: LASSO MODEL #: D-1220-38-S, LOT #.: 15671156L. LASSO MODEL #: D-1220-39-S, LOT #.: 15582626L. CARTO XP SYSTEM MODEL #: M-4700-01, SERIAL #: (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    REF: (B)(4). 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. IN ADDITION, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. FINALLY, THE RETURNED DEVICE WAS TESTED FOR EEPROM, CARTO, 4KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER PASSED THESE TESTS. CATHETER WAS PROPERLY VISUALIZED DURING TEST. THE DEVICE HISTORY RECORD 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 IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. SINCE THE CATHETER PASSED SPECIFICATIONS, THE ROOT CAUSES OF THE PERICARDIAL EFFUSION AND THE SIGNAL ISSUE REMAIN UNKNOWN.

    Description of Event or Problem · 1

    DURING THE ATRIAL FIBRILLATION PROCEDURE, ARTIFACT WAS OBSERVED ON THE ABLATION CATHETER ON THE EP RECORDING SYSTEMS, BUT SIGNALS WERE DISPLAYING FINE ON CARTO XP. TROUBLESHOOTING WAS PERFORMED BUT ISSUE COULD NOT BE RESOLVED. ABLATION WAS CONTINUED WITH SIGNALS ONLY DISPLAYED ON CARTO ONLY. AFTER ONE ROUND OF THE LEFT PULMONARY VEIN ISOLATION, THE PHYSICIAN NOTICED THAT THE MOTION OF THE POSTERIOR WALL BECAME DETERIORATED. NO BLOOD PRESSURE REDUCTION WAS OBSERVED; HOWEVER; PERICARDIAL EFFUSION WAS CONFIRMED BY AN ECHOCARDIOGRAM. PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE WAS ENDED. THE MOTION OF THE POSTERIOR WALL AND BLOOD PRESSURE RECOVERED AFTER PERICARDIOCENTESIS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-01-S 15635345M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R