BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3160121 · Received June 10, 2013

    Report

    Report Number
    9673241-2013-00180
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND IT WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). THE PATIENT WAS REPORTED STABLE AND WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR 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, A COOL FLOW PUMP TEST WAS PERFORMED AND THE CATHETER PASSED SPECIFICATIONS. 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION 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); ISMUS CATHETER US CATALOG #: D7A20131RT LOT #: 15786363M; WEBSTER 8 POLE CATHETER US CATALOG #: D708DR002RT LOT #: 15670996M; WEBSTER 6 POLE CATHETER US CATALOG #: 1086259RT LOT #: 157684872M; WEBSTER 4 POLE CATHETER US CATALOG #: D7DR252RT LOT #: 15770511M; LASSO NAV VARIABLE ECO CATHETER US CATALOG #: D134301 LOT #: 15734508L; COOLFLOW TUBING SET US CATALOG #: CFT001 OEM LOT #: 966033. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND IT WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). PROTAMINE WAS GIVEN TO THE PATIENT TO REVERSE HEPARIN. THE PATIENT WAS REPORTED STABLE AND WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THREE ATTEMPTS TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT WERE REQUESTED TO THE CUSTOMER WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260984 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15654455L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L