BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3843263 · Received June 2, 2014

    Report

    Report Number
    9673241-2014-00209
    Event Type
    Death
    Date Received
    June 2, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT'S HEART STOPPED SUDDENLY WHILE MAPPING IN THE VENTRICLE; ABLATION HAD BEEN PERFORMED PRIOR TO MAPPING. THE STOPPED HEART WAS NOTED ON ICE AND THE CPR WAS STARTED IMMEDIATELY. THE PATIENT RECOVERED FOR ABOUT 20 MINUTES BEFORE THE HEART STOPPED AGAIN. CPR WAS THEN PERFORMED AGAIN AND THE PATIENT EXPIRED. 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, 4 KHZ AND CALIBRATION FUNCTIONALITY. 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. 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 PATIENT EXPIRATION 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

    THE CONCOMITANT PRODUCTS: SOUNDSTAR CATHETER: (B)(4) (DISPOSED OF, LOT # S1403856). WEBSTER CATHETER: 1086259RT (DISPOSED OF, LOT # 16060680M.) CARTO 3 SN: (B)(4). STOCKERT SN: ST-(B)(4). COOLFLOW PUMP SN: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEART STOPPED SUDDENLY WHILE MAPPING IN THE VENTRICLE, ABLATION HAD BEEN PERFORMED PRIOR TO MAPPING. THE STOPPED HEART WAS NOTED ON ICE AND THE CPR WAS STARTED IMMEDIATELY. THE PATIENT RECOVERED FOR ABOUT 15 TO 20 MINUTES BEFORE THE HEART STOPPED AGAIN. CPR WAS THEN PERFORMED AGAIN AND THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT THE PATIENT WAS VERY SICK. THE PATIENT HAD LOW EJECTION FRACTION, VENTRICULAR FIBRILLATION (VF) STORMS THE NIGHT BEFORE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE PROCEDURE-RELATED AND UNRELATED TO PROCEDURE OR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321367 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-04-S 16055263L

    Patients

    Seq Age Sex Outcome Treatment
    1 Death