BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8511721 · Received April 12, 2019

    Report

    Report Number
    2029046-2019-02978
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 19, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IN THE INITIAL REPORT, THE MANUFACTURE ADDRESS WAS ERRONEOUSLY REPORTED AS 31 TECHNOLOGY DR. IRVINE, CA 92618. THE CORRECT ADDRESS IS 33 TECHNOLOGY DR. IRVINE, CA 92618. THE INVESTIGATIONAL ANALYSIS COMPLETED 4/15/2019. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED. NO ERRORS WERE OBSERVED. THE FORCE SENSOR WAS TESTED AND IT WAS FOUND TO BE WORKING PROPERLY. THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. ELECTRICAL TESTING WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR. THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. IRRIGATION AND DEFLECTION TESTING WAS PERFORMED AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED.  THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATE THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 4/2/2019. INITIAL VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. ON 4/3/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS RELATED TO THIS COMPLAINT WERE FOUND DURING THE REVIEW. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 300 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CORONARY CARE UNIT (CCU) FOR OBSERVATION PURPOSES. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION, PATIENT¿S OUTCOME AND PHYSICIAN¿S CAUSALITY OPINION. 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
    302098 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30136431L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R