BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3131880 · Received May 29, 2013

    Report

    Report Number
    9673241-2013-00173
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT 1.5 HOURS INTO AN ATRIAL FIBRILLATION (A-FIB) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION THAT WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AFTER THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN DIDN¿T CONSIDER THAT THE EVENT¿S CAUSALITY WAS DUE TO ANY MALFUNCTION OF BWI PRODUCTS. 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 ALSO 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

    INVESTIGATION IS STILL IN PROCESS. A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: U.S. CATALOG #: FG540000, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: U.S. CATALOG #: S7001, SERIAL #: (B)(4). COOL FLOW PUMP: U.S. CATALOG #: CFP002, SERIAL #: (B)(4). REPROCESSED SOUNDSTAR CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1.5 HOURS INTO AN ATRIAL FIBRILLATION (A-FIB) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION THAT WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AFTER THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN HAD BEEN ABLATING AT 40 WATTS WITH A THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER AND THE FLOW RATE OF THE COOL FLOW PUMP WAS 15 ML/MIN. AFTER FOLLOW UP WITH THE CUSTOMER TO GET DETAILED INFORMATION REGARDING THE EVENT IT WAS CONFIRMED THAT PERICARDIOCENTESIS WAS PERFORMED. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED AND ACCORDING WITH THE LAB STAFF THE PROGNOSIS OF THE PATIENT WAS GOOD. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE PROCEDURE RELATED. THE PHYSICIAN DIDN¿T CONSIDER THAT THE EVENT¿S CAUSALITY WAS DUE TO ANY MALFUNCTION OF BWI PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237246 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-04-S 15841618L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R