BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7513422 · Received May 15, 2018

    Report

    Report Number
    2029046-2018-01548
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 17, 2018
    Report Date
    April 17, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURE DATE AND EXPIRATION DATE IN ADDITION TO THE DEVICE HISTORY RECORD WERE RECEIVED ON WAS RECEIVED ON MAY 16, 2018. THE CORRESPONDING FIELDS WERE UPDATED WITH THIS INFORMATION. MANUFACTURING DATE: 2017/12/04 EXPIRATION DATE: 2018/12/03. IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2018. 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. STILL PENDING IS THE MANUFACTURED DATE AND THE EXPIRATION DATE. THEREFORE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO UPDATE. EXPIRATION DATE. MANUFACTURED DATE. CONCOMITANT PRODUCTS: NON-BIOSENSE WEBSTER, INC.- COOK MEDICAL 71 CM TRANSSEPTAL NEEDLE NON-BIOSENSE WEBSTER, INC.- BOSTON SCIENTIFIC ZURPAZ SHEATH CARTO 3 SYSTEM, US CATALOG #: FG540000, SERIAL #:(B)(4); SMARTABLATE GENERATOR , US CATALOG #: M490007, SERIAL #: (B)(4); SMARTABLATE PUMP , US CATALOG #: M490008, SERIAL #: (B)(4); LASSO NAV 2515,22P SPLITHANDLE, US CATALOG #: UNKNOWN, LOT #: UNKNOWN; MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, AFTER ABLATION, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS NOTED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED APPROXIMATELY 200 ML. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT OUTCOME IS IMPROVED. PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. MEDICAL HISTORY INCLUDES A PREVIOUS ABLATION IN 2015. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. IT IS UNKNOWN DURING WHICH PHASE THE ADVERSE EVENT OCCURRED. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED X 2 WITH A COOK MEDICAL 71 CM TRANSSEPTAL NEEDLE AND A BOSTON SCIENTIFIC ZURPAZ SHEATH. GENERATOR WAS SET ON POWER CONTROL MODE AT 30 WATTS. IT WAS NOTED THAT THERE WERE NO SIGNIFICANT CHANGES IN IMPEDANCE. POWER WAS NOT TITRATED DURING ABLATION. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 8 ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME (ACT) MAINTAINED BETWEEN 300-350 SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355878 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17764156L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R