BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8373836 · Received February 27, 2019

    Report

    Report Number
    2029046-2019-02731
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 31, 2019
    Report Date
    January 31, 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

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON MARCH 4, 2019 AND WAS VISUALLY INSPECTED AND IT WAS FOUND TO HAVE REDDISH/BROWN MATERIAL (CHAR) ON THE DOME. THE ISSUE OF CHAR IS CONSIDERED A NOT REPORTABLE EVENT. IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING PHASE, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200 ML OF FLUID FROM THE PERICARDIUM. THE CASE CONTINUED WITHOUT FURTHER INCIDENTS. THE PATIENT REQUIRED OF EXTENDED HOSPITALIZATION IN THE INTENSIVE CARE UNIT (ICU). PATIENT¿S OUTCOME IS FULLY RECOVERED. PATIENT WAS DISCHARGED AFTER 4 DAYS. THE DEVICE WAS VISUALLY INSPECTED AND REDDISH MATERIAL (CHAR) WAS OBSERVED ON THE TIP. 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. THE CHAR OBSERVED IS A PHYSICAL PHENOMENON OF RADIO FREQUENCY; IT CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS; HOWEVER, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. MANUFACTURER'S REFERENCE # (B)(4).

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30104475L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CONCOMITANT MEDICAL PRODUCTS: BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM, CATALOG #: FG540000, SERIAL #: (B)(4); BIOSENSE WEBSTER, INC. PRODUCT - SMARTABLATE GENERATOR KIT-US, CATALOG #: M490007, SERIAL #: (B)(4); BIOSENSE WEBSTER, INC. PRODUCT - PENTARAY CATHETER, CATALOG #: UNKNOWN, LOT #: UNKNOWN; NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL 8.5FR. AGILIS SHEATH, CATALOG #: 408309, LOT # : UNKNOWN. MANUFACTURER'S REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING PHASE, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200 ML OF FLUID FROM THE PERICARDIUM. THE CASE CONTINUED WITHOUT FURTHER INCIDENTS. THE PATIENT REQUIRED OF EXTENDED HOSPITALIZATION IN THE INTENSIVE CARE UNIT (ICU). PATIENT¿S OUTCOME IS FULLY RECOVERED. PATIENT WAS DISCHARGED AFTER 4 DAYS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. AGILIS CATHETER SUPPORT AND HIGH FORCE READINGS WERE CITED AS FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. A ST. JUDE MEDICAL AGILIS 8.5 FR SHEATH WAS USED. NO ABLATION WAS PERFORMED PRIOR TO THE EVENT. THE CATHETER IRRIGATION WAS SET AT 2 ML/MIN. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE CATHETER 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 THE INDICATE TO RE-ZERO THE CATHETER. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. THE ISSUE OF HIGH FORCE IS CONSIDERED NOT REPORTABLE AS THE READING IS A HIGHLY DETECTABLE ISSUE WHEN OCCURRING. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167686 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30124992L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R