BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8476535 · Received April 2, 2019

    Report

    Report Number
    2029046-2019-02926
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 3, 2019, PROVIDING A CORRECTION TO THE CATALOG AND LOT #¿S OF ONE OF THE CONCOMITANT PRODUCTS. IT WAS INITIALLY REPORTED WITH: BIOSENSE WEBSTER, INC. PRODUCT - SOUNDSTAR ECO 8FG ULTRASOUND CATHETER. CATALOG #: E8148996. LOT #: 10439011. HOWEVER, THE CORRECT INFORMATION IS AS FOLLOWS: BIOSENSE WEBSTER, INC. PRODUCT - SOUNDSTAR ECO 8FG ULTRASOUND CATHETER. CATALOG #: 10439011. LOT #: E8148992. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON (B)(6) 2019, IT WAS NOTED THAT ¿. MANUFACTURER ADDRESS STREET LINE 1¿ ON THE 3500A INITIAL REPORT NEEDED CORRECTION. IT WAS INITIALLY SUBMITTED AS ¿31 TECHNOLOGY DRIVE¿. THE CORRECT ADDRESS IS ¿33 TECHNOLOGY DRIVE¿. THEREFORE, ¿. MANUFACTURER ADDRESS STREET LINE 1¿ HAS BEEN RE-POPULATED. INVESTIGATION SUMMARY IT WAS REPORTED THAT A 62-YEAR-OLD FEMALE 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 ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 770 ML OF FLUID FROM THE PERICARDIUM. THE PATIENT STAYED AN EXTRA NIGH FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME IS FULLY RECOVERED. 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 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 TEST WERE PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30145900L NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. CONCOMITANT PRODUCTS: NON-BIOSENSE WEBSTER, INC. PRODUCT - MERIT MEDICAL - HEARTSPAN TRANSSEPTAL NEEDLE, CATALOG #: UNKNOWN, LOT #: UNKNOWN; BIOSENSE WEBSTER, INC. PRODUCT - SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, CATALOG #: E8148996, LOT #: 10439011; BIOSENSE WEBSTER, INC. PRODUCT - PENTARAY CATHETER, CATALOG #: D128211, LOT #: 30157533L; BIOSENSE WEBSTER, INC. PRODUCT - CARTO 3 SYSTEM, CATALOG #: UNKNOWN, SERIAL #: (B)(4). MANUFACTURER'S REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE 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 ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 770 ML OF FLUID FROM THE PERICARDIUM. THE PATIENT STAYED AN EXTRA NIGH FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN BELIEVES THE EVENT OCCURRED WHEN ABLATING THE ROOF OF THE LEFT ATRIUM, HE MIGHT HAVE GONE THROUGH THE TISSUE CAUSING THE EFFUSION. TRANSSEPTAL NEEDLE WAS PERFORMED WITH A HEARTSPAN TRANSSEPTAL NEEDLE. DURING THE ABLATION, THE FORCE VALUE WAS WITHIN REASONABLE LIMITS, THERE WAS NO SUDDEN RISE IN THE IMPEDANCE VALUE AND THERE WAS NO EVIDENCE OF STEAM POP. THE CATHETER IRRIGATION WAS SET AT A RATE OF 15 ML/MIN. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER AND IT WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE SHAFT PROXIMITY INTERFERENCE (SPI) WAS 0.0. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT ON APRIL 1, 2019. THE INITIAL VISUAL INSPECTION REVEALED THAT THERE WAS NO PHYSICAL DAMAGE OR ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266312 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30145900L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R