BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3863868 · Received June 10, 2014

    Report

    Report Number
    2029046-2014-00163
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # (B)(4). PRODUCT: STOCKERT 70 RF GENERATOR, US CATALOG # S7001, SERIAL # (B)(4). PRODUCT: COOLFLOW® IRRIGATION PUMP, US CATALOG # CFP002, SERIAL # (B)(4). PRODUCT: LASSO¿ ELECTROPHYSIOLOGY CATHETER, US CATALOG # D7L2020RT, LOT # UNKNOWN. PRODUCT: WEBSTER® CS CATHETER WITH EZ STEER¿ TECHNOLOGY, US CATALOG # BD710DF282RTS, LOT # UNKNOWN. B) MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A NOISE SIGNAL DEVICE MALFUNCTION OCCURRED. THE CARTO 3 SYSTEM WAS DISPLAYING AN ERROR 21. TROUBLESHOOTING WAS PERFORMED: ALL THREE CATHETERS WERE UNPLUGGED AND THE PATIENT INTERFACE UNIT (PIU) REBOOTED. WHEN THE PIU WAS FULLY BOOTED UP, THE CATHETERS STARTING WITH THE ABLATION WERE PLUGGED IN. WITH THE ABLATION CATHETER PLUGGED IN, THE ECG WERE SATURATED. THE ABLATION CATHETER WAS UNPLUGGED AND THE ECG CLEARED. THEN CATHETERS WHERE PLUGGED IN THE REF/DECA AND THEN THE 20 B, NO ISSUES WERE NOTED. THE ABLATION CABLE WAS REPLACED AND WHEN THE ABLATION CATHETER WAS PLUGGED IN, THE ISSUE WAS RESOLVED. ABOUT 30 MINUTES LATER, THERE WAS SUDDENLY A LOT OF MAGNETIC NOISE ON THE ECG FOR BOTH CARTO 3 AND THE RECORDING SYSTEM THAT LOOKED LIKE A VERY RAPID VENTRICULAR TACHYCARDIA (VT). THE ANESTHESIA MACHINES ALSO RECORDED THIS ABNORMAL ECG. THE PHYSICIAN REQUESTED FOR A STAT ECHO AND CARDIOVERTED THE PATIENT WITHOUT SUCCESS. THE ABLATION CATHETER WAS UNPLUGGED FROM THE PIU AND ALL THE ECG'S RETURNED TO NORMAL. THE ABLATION CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. THERE WERE NO PATIENT CONSEQUENCES. THIS EVENT IS BEING REPORTED BECAUSE DUE TO THE UNNECESSARY CARDIOVERSION PERFORMED THAT MIGHT CONTRIBUTE A POTENTIAL RISK TO THE PATIENT. THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340792 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1317-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1