BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3230640 · Received July 16, 2013

    Report

    Report Number
    9673241-2013-00233
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IT VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL: M-5463-01, SERIAL #:(B)(4). COOLFLOW PUMP: MODEL #: M-5491-02, SERIAL #:(B)(4). WEBSTER CS WITH AUTO ID CATHETER: MODEL #:D-1353-04-S, LOT #:15740356M. LASSO NAV VARIABLE ECO CATHETER: MODEL #: D-1343-01-S, LOT #: 15849305L. ACUNAV CATHETER (DISTRIBUTED PRODUCT): MODEL #: M-5723-07, LOT #: OEM_M-5723-07. MANUFACTURER'S REF. NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). IT WAS REPORTED THAT THE PATIENT WAS ONLY UNDER OBSERVATION AND THAT NO TREATMENT WAS ADMINISTERED TO THE PATIENT. THE PATIENT WAS REPORTED IN RECOVERY AND IN STABLE CONDITION. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. THE EVENT OCCURRED DURING THE ABLATION PHASE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY WAS THAT HE WAS UNCERTAIN AS TO WHETHER THE SMALL EFFUSION WAS PRE-EXISTING OR WHETHER HE HAD CAUSED IT AND HOW HE MAY HAVE CAUSED IT. THERE WERE NO OTHER FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THERE WAS APPROXIMATELY 10 ¿ 15 ABLATION APPLICATIONS DELIVERED TO THE PATIENT BEFORE THE EVENT. THE RF GENERATOR WAS SET TO ¿POWER-CONTROL¿ MODE. THE POWER WAS SET TO 30 WATTS. THE TEMPERATURE CUT-OFF SETTING WAS SET TO 42 DEGREES AND THE FLOW SETTING WAS SET TO 15 ML/MIN. THE SHEATH USED WAS THE ST. JUDE SL1. THE ACT MAINTAINED DURING THE PROCEDURE WAS >350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330053 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-02-S 15838381L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L