BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4798439 · Received May 27, 2015

    Report

    Report Number
    9673241-2015-00322
    Event Type
    Death
    Date Received
    May 27, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 28, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6) YEARS OLD, UNDERWENT A PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIOGENIC SHOCK AND THE PATIENT EXPIRED. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT HAD A VENTRICULAR EXTRASYSTOLE (VES) IN THE LEFT VENTRICLE (LV). THE ORIGIN WAS FROM THE LEFT MITRAL VALVE NEAR THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VES WAS TREATED WITH PRECISE RADIO FREQUENCY DELIVERY USING A SMART TOUCH BIDIRECTIONAL CATHETER. CORONARY ANGIO WAS DONE BEFORE AND AFTER THE RADIO FREQUENCY ABLATION TO ENSURE THAT THERE WAS ENOUGH DISTANCE TO THE LAD. THERE WAS NO VES OBSERVED AFTER THE ABLATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THIS TIME. ABOUT 6 HOURS AFTER THE ABLATION, THE PATIENT DEVELOPED HEAVY THROMBUS IN THE LAD THAT CAUSED A CARDIAC SHOCK. ALL ACTIONS FOR SAVING THE PATIENT WERE TAKEN WITHOUT SUCCESS AND THE PATIENT EXPIRED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THE THROMBUS IN THE LAD CAUSED THE PATIENT¿S DEATH AND THAT THE BIOSENSE PRODUCT WAS NOT RELATED TO THIS ISSUE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344003 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-00-S UNKNOWN_D-1327-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death| R