BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8140228 · Received December 6, 2018

    Report

    Report Number
    2029046-2018-02408
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 12, 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

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A 72-YEAR-OLD PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTICED A SMALL PERICARDIAL EFFUSION. DURING THE PROCEDURE, PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 600 CC OF FLUID FROM THE PERICARDIUM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. ONE EXTRA DAY OF HOSPITALIZATION WAS REQUIRED FOR MONITORING 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. 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 (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 12/18/2018. THEREFORE, POPULATED DEVICE AVAILABLE FOR EVALUATION? IS DEVICE RETURNED TO MANUFACTURER? AND DATE DEVICE RETURNED TO MANUFACTURER. 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 REF. NO: (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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. CONCOMITANT PRODUCTS: 1. NON-BIOSENSE WEBSTER, INC. PRODUCT - 71CM COOK TRANSSEPTAL NEEDLE ; 2. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL SL0 8.5 FR SHEATH; 3. BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM, U.S. CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND LASSO® NAV ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTICED A SMALL PERICARDIAL EFFUSION. DURING THE PROCEDURE, PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 600 CC OF FLUID FROM THE PERICARDIUM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. ONE EXTRA DAY OF HOSPITALIZATION WAS REQUIRED FOR MONITORING PURPOSES. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. PHYSICIAN STATED THAT THE PERFORATION COULD HAVE OCCURRED EITHER DURING MAPPING WITH A LASSO® NAV ECO CATHETER IN THE RIGHT ATRIUM OR DURING ABLATION WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER TO THE ANTERIOR WALL OF THE LEFT ATRIUM. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A 71 CM COOK TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL SL0 8.5 FR SHEATH. GENERATOR WAS USED IN POWER CONTROL MODE AT 30 WATTS. THE POWER DID NOT TITRATE DURING THE PROCEDURE. THE OVERALL TIME FOR ABLATION WAS OVER ONE HOUR AND THE LAST ABLATION CYCLE TIME WAS OF 20-40 SECONDS AT 30 WATTS. THE CATHETER IRRIGATION WAS SET AT 8 CC/MIN. THE PATIENT RECEIVED ANTICOAGULANT (UNSPECIFIED) DURING THE PROCEDURE. THE ACTIVATED CLOTTING TIME (ACT) WAS OF 300-350 SECONDS. 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. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978482 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R