BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3240794 · Received July 22, 2013

    Report

    Report Number
    9673241-2013-00246
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE ABLATION CATHETER WAS DISPLAYED OUTSIDE OF THE SHELL OF THE HEART ON THE CARTO MAP. THE PHYSICIAN USED X-RAY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND PERFORATION WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED AND 800 CC OF FLUID WAS REMOVED. PATIENT WAS STABILIZED AND UNDER OBSERVATION. 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 CATHETER WAS EVALUATED FOR EEPROM, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER FAILED CALIBRATION FUNCTIONALITY. FURTHER EXAMINATION SHOWED THAT THE SENSOR WAS WITHIN SPECIFICATIONS. ACCORDING TO THE CALIBRATION RESULTS AND THE SENSOR READINGS, THE IMPROPER CONDITION WAS ATTRIBUTED TO AN INTERNAL LEAKAGE IN THE SENSOR CABLE. THE CATHETER FAILED THE CALIBRATION FUNCTIONALITY TEST DUE TO AN INTERNAL LEAKAGE IN THE SENSOR CABLE. HOWEVER, THE ROOT CAUSE OF THE PERFORATION REMAINS UNKNOWN. 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 IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US: CATALOG #: FG540000, SERIAL #: (B)(4). STOCKERT 70 SYSTEM US: CATALOG #: S7001, SERIAL #: (B)(4). COOL FLOW PUMP US: CATALOG #: CFP002, SERIAL #: (B)(4). LASSO NAV VARIABLE ECO US: CATALOG #: D134302, LOT #: 15839684L. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE ABLATION CATHETER WAS DISPLAYED OUTSIDE OF THE SHELL OF THE HEART ON THE CARTO MAP. THE PHYSICIAN USED X-RAY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND PERFORATION WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED AND 800 CC OF FLUID WAS REMOVED. PATIENT WAS STABILIZED AND UNDER OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED TO THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND ON (B)(6) 2013, IT WAS STATED THAT THE PHYSICIAN WAS ABLATING AROUND THE RIGHT SUPERIOR PULMONARY VENTRICLE (RSPV) AND THE PHYSICIAN COULD NOT GET BLOCK EVEN THOUGH HE HAD BEEN WORKING ON IT FOR 30 MINUTES. THE PHYSICIAN WAS ABLATING THE ROOF AND THE CATHETER APPEARED TO HAVE GONE OUT OF THE HEART CT. THE PHYSICIAN LOOKED AT X-RAY AND SAW THAT THE CATHETER WAS OUT OF THE HEART SHADOW. THE PATIENT¿S BLOOD PRESSURE BEGAN TO DROP. THE DOCTOR THEN PUT THE CRYO BALLOON IN THE HEART IN CASE THE VEIN WAS PERFORATED WHICH DID NOT SEAL THE LEAK. THEREFORE, THE PHYSICIAN COMPLETED A PERICARDIOCENTESIS AND FROZE THE RSVP AND RIGHT INFERIOR PULMONARY VENTRICLE (RIPV). THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE EVENT STATED THAT IT WAS PROCEDURE RELATED SINCE HE WAS ABLATING ON THE ROOF AND TOO MUCH PRESSURE AND WATTS WERE APPLIED. THE CATHETER WENT THROUGH THE ATRIUM. THE OUTCOME OF THE ADVERSE EVENT WAS IDENTIFIED AS FULLY RECOVERED. AN AGILIS LONG SHEATH WAS USED (COMPETITOR¿S SHEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340056 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-04-S 15807320M

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R