BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8973010 · Received September 8, 2019

    Report

    Report Number
    2029046-2019-03617
    Event Type
    Injury
    Date Received
    September 8, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009002
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A MALE PATIENT (95KG) TREATED WITH XARELTO AND SOTALOL UNDERWENT A REDO ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERFORATION OF THE LEFT ATRIAL APPENDAGE (LAA) AND PERICARDIAL EFFUSION WERE NOTICED AS THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 1.4 LITERS OF FLUID FROM THE PERICARDIAL SPACE. PATIENT¿S OUTCOME IS FULLY RECOVERED, THE PATIENT WAS RELEASED WITHIN 48 HOURS. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITION. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, THE FORCE SENSOR WAS TESTED, AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, THE IRRIGATION AND DEFLECTION TESTS WERE PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30213251M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE # : (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT ((B)(6)) TREATED WITH XARELTO AND SOTALOL UNDERWENT A REDO ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERFORATION OF THE LEFT ATRIAL APPENDAGE (LAA) AND PERICARDIAL EFFUSION WERE NOTICED AS THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 1.4 LITERS OF FLUID FROM THE PERICARDIAL SPACE. PATIENT¿S OUTCOME IS FULLY RECOVERED, THE PATIENT WAS RELEASED WITHIN 48 HOURS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO PERFORATE THE RIGHT SUPERIOR SIDE OF THE LAA AND THAT IT WAS PATIENT CONDITION RELATED. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED DURING THE CASE AS THE PATIENT HAS A PATENT FORAMEN OVAL (PFO). THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE ISSUE MOST LIKELY OCCURRED IN MAPPING PHASE BUT WAS NOTED POST ABLATION. THE FLOW WAS SET BETWEEN 15-30 ML/MIN. THE FORCE VISUALIZATION FEATURES USED DURING THE CASE INCLUDED GRAPH, DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 3 MM FOR 3S AND 25% FOT 3G. NO ADDITIONAL FILERS WERE USED WITH THE VISITAG MODULE. THE COLOR OPTION USED PROSPECTIVELY WERE AVERAGE AND FORCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON AUGUST 27, 2019, AND IT WAS IT WAS NOTED THAT ON INITIAL VISUAL INSPECTION THAT THERE WAS NO VISUAL DAMAGE OR ANOMALIES OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766841 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30213251M 10846835009002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R