BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7985934 · Received October 19, 2018

    Report

    Report Number
    2029046-2018-02190
    Event Type
    Death
    Date Received
    October 19, 2018
    Date of Event
    August 20, 2018
    Report Date
    September 21, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE INFORMATION OF THE BIOSENSE WEBSTER, INC. BWI ABLATION CATHETER USED DURING THE PROCEDURE. HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THEREFORE, AN IMPACTED PRODUCT FOR AN ABLATION CATHETER HAS BEEN CREATED USING A GENERIC CODE (THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT AND/OR THE ABLATION CATHETER, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# FG-5400-00C, SERIAL # UNKNOWN); STEREOTAXIS SYSTEM (MODEL# UNKNOWN, LOT# UNKNOWN). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT IN THEIR (B)(6) UNDERWENT A PREMATURE VENTRICULAR CONTRACTION/VENTRICULAR TACHYCARDIA (PVC/VT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC PERFORATION (REQUIRING SURGICAL INTERVENTION) THAT LED TO DEATH. THE ABLATION PROCEDURE WAS BEING DONE IN THE RIGHT VENTRICLE IN THE RIGHT VENTRICULAR OUTFLOW TRACK (RVOT) AREA. AT THE END OF THE PROCEDURE, DURING ABLATION, THE STEREOTAXIS SYSTEM HAD NOISE ON THE COVERS. ADDITIONALLY, STEAM POP WAS HEARD. CARDIAC PERFORATION OCCURRED, AND THE PATIENT REQUIRED OPEN CHEST SURGERY. THE PHYSICIAN ATTEMPTED TO REPAIR THE AREA DAMAGED BY THE STEAM POP. THE SURGERY WAS UNSUCCESSFUL, AND THE PATIENT DIED. THE PATIENT DID NOT RECEIVE ANTICOAGULANT DURING THE PROCEDURE. HOWEVER, THE INTRAVENOUS SALINE HAD HEPARIN. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BIOSENSE WEBSTER INC. BWI EQUIPMENT DURING THE PROCEDURE. THERE'S NO INFORMATION REGARDING PHYSICIAN CAUSALITY OPINION. HOWEVER, PHYSICIAN DID NOT BELIEVE THAT THE STEREOTAXIS SYSTEM CONTRIBUTED TO THE ADVERSE EVENT. THE SITE VISIT PROCEDURE FILE DETAILS WERE PROVIDED FROM STEREOTAXIS. FILE DETAILS INCLUDED THAT AFTER THE ABLATION PROCEDURE, SYSTEM NOISE WAS INVESTIGATED BY STEREOTAXIS. DURING THE VISIT, IT WAS DISCOVERED THAT THE STEREOTAXIS NIOBE POSITIONER 1 ENCOUNTERED AN UNRECOVERABLE FAULT WITH THE COVER AXIS REVERSE LIMIT SWITCH. WHEN MOVING TO THE STOWED POSITION THE NIOBE COVERS WERE RETRACTING AWAY FROM THE PATIENT TABLE. THIS EASILY COULD HAVE BEEN CAUSED BY AN OBSTRUCTION IN THE POSITIONER'S PHYSICAL PATH WHILE MOVING TO STOWED. THE ERROR LIKELY OCCURRED WHEN THEY WERE MOVING THE STEREOTAXIS SYSTEM WHEN THE ADVERSE EVENT OCCURRED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE STEAM POP ISSUE IS NOT CONSIDERED REPORTABLE. STEAM POP IS AN EXPECTED PHYSIOLOGICAL PHENOMENON. THIS COMPLAINT HAS BEEN ASSESSED AS REPORTABLE AS ANY SERIOUS INJURY THAT RESULTS IN THE DEATH OF THE PATIENT IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824523 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R