BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3240784 · Received July 22, 2013

    Report

    Report Number
    9673241-2013-00244
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, THEREFORE NO DEVICE INVESTIGATION COULD BE CONDUCTED. DEVICE HISTORY RECORDS 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. CONCOMITANT PRODUCTS: STOCKERT US CATALOG #: S7036, SERIAL #: (B)(4). CARTO 3 US CATALOG #: FG540000J, SERIAL #: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, AFTER SOUND MAP WAS CREATED BY SOUNDSTAR, A BROCKENBROUGH WAS CONDUCTED. THE SHEATH WAS APPROACHED TO LEFT ATRIUM AND RIGHT VENTRICLE (RV) AND PACING WAS PERFORMED. THE ELECTRIC POTENTIALS WERE REDUCED ONE-TENTH AT THE DISTAL END OF THE RV CATHETER AFTER THE RV PACING COMPARED TO THE PRIOR PACING. THE PHYSICIAN SUSPECTED THAT THE CATHETER DIDN¿T TOUCH THE CARDIAC WALL AND HE RE-PLACED THE RV CATHETER. THE ELECTRIC POTENTIALS WERE RESTITUTED. THEN, ANGIOGRAPHY WAS PERFORMED AND A LIBERO (COMPETITOR¿S CATHETER) WAS PLACED IN LEFT SUPERIOR PULMONARY VEIN (LSPV) AND ABLATION WAS DELIVERED. RV ABLATION WAS DELIVERED TWICE AT 30W FOR 30 SECONDS. WHEN THE 3RD ABLATION WAS DELIVERED AFTER 10 MINUTES SINCE THE ABLATION STARTED, THE PATIENT¿S BLOOD PRESSURE DROPPED FROM 120 TO 34. TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND PERICARDIAL EFFUSION WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED, BUT THE BLOOD PRESSURE DIDN¿T RECOVER. THEREFORE, PERICARDIOCENTESIS WITH OPENING ABDOMINAL CAVITY WAS PERFORMED. THE SYSTOLIC BLOOD PRESSURE WAS RECOVERED TO 40, BUT IT DIDN¿T RECOVER ANY FURTHER. TRANSFUSION WAS PERFORMED FOR 2 HOURS AND THEN BLOOD CONSERVATION SYSTEM WAS SECURED TO THE PATIENT SINCE THE HEARTH RATE FELL BELOW 60/MIN, RV PACING WAS PERFORMED. THIS CONDITION BROUGHT A VENTRICULAR FIBRILLATION (VF) AND DEFIBRILLATION WAS PERFORMED FOR SEVERAL TIMES. FINALLY INTRA-AORTIC BALLOON PUMP (IABP) AND PCPS WERE INSERTED AND THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU). THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE EVENT STATED THAT IT MIGHT BE DUE TO THE FACT THAT THE COMPETITOR¿S RV CATHETER PERFORATED THE CARDIAC CAVITY DURING RV PACING. THE PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341256 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-01-S 15803464L

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R