BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR? THERMO-COOL? ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3311636 · Received August 27, 2013

    Report

    Report Number
    9673241-2013-00292
    Event Type
    Injury
    Date Received
    August 27, 2013
    Report Date
    August 9, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH THE ACCOUNT TRYING TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND PRODUCTS INVOLVED STILL IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCT: CARTO 3 RMT SYSTEM US CATALOG #: FG560000, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, BASED ON A LITERATURE REVIEW OF THE JOURNAL OF THE AMERICAN HEART ASSOCIATION, CIRCULATION. AN EVENT WAS DOCUMENTED AS FOLLOW: RELEVANT VENTRICULAR SEPTAL DEFECT CAUSED BY STEAM POP DURING ABLATION OF PREMATURE VENTRICULAR CONTRACTION CASE INVOLVING A CARTO-3 RMT SYSTEM AND NAVISTAR THERMOCOOL CATHETER. THE PATIENT WITH HIGHLY SYMPTOMATIC, IDIOPATHIC, MONOMORPHIC, PREMATURE VENTRICULAR CONTRACTION PRESENTED AT THE HOSPITAL FOR FURTHER TREATMENT. PREVIOUS MEDICAL ANTIARRHYTHMIC TREATMENT HAS FAILED. THE PATIENT HAD A HISTORY OF MITRAL VALVE REPAIR ATTRIBUTABLE TO RHEUMATIC HEART DISEASE 2 YEARS BEFORE AND PAROXYSMAL ATRIAL FIBRILLATION. ASIDE FROM THAT, TRANSTHORACIC ECHOCARDIOGRAM REVEALED NO STRUCTURAL HEART DISEASE. INDICATION WAS SET FOR CATHETER ABLATION. AFTER TRANSSEPTAL PUNCTURE (BRK-0 TRANSSEPTAL NEEDLE, (B)(4)) A LEFT VENTRICULAR ELECTRO ANATOMIC ACTIVATION MAP OF THE PREMATURE VENTRICULAR CONTRACTION WAS DONE USING THE CARTO-3 RMT SYSTEM (BWI). THE SITE OF EARLIEST ACTIVATION WAS FOUND IN AN INFEROSEPTAL APICAL POSITION. DURING RADIOFREQUENCY ABLATION AT THIS SITE WITH A 3.5-F EXTERNAL IRRIGATED TIP CATHETER (NAVISTAR THERMOCOOL, BWI) WITH 50 W AND MAX TEMPERATURE OF 46°C SUDDENLY A LOUD STEAM POP OCCURRED, TOGETHER WITH AN IMPEDANCE DROP OF 34 OHMS. HOWEVER, BLOOD PRESSURE STAYED STABLE FOR THE REST OF THE PROCEDURE AND PERICARDIAL EFFUSION WAS RULED OUT IMMEDIATELY AFTER STEAM POP, AFTER THE PROCEDURE, AND THE NEXT DAY. TWO WEEKS AFTER THE ABLATION PROCEDURE, THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNOEA. AN ECHOCARDIOGRAM REVEALED A VENTRICULAR SEPTAL DEFECT AND INDICATION WAS SET FOR SURGICAL REPAIR. THE PATIENT WAS DISCHARGED ON NINTH POSTOPERATIVE DAY. NO INFORMATION ON THE EVENT DATE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420463 NAVI-STAR? THERMO-COOL? ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S UNKNOWN_D-1197-17-S_JUA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R