BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 7478741 · Received May 2, 2018

    Report

    Report Number
    2029046-2018-01503
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 12, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: NON-BIOSENSE WEBSTER, INC.- ST. JUDE MEDICAL/ABBOTT AGILIS SHEATH. CARTO 3 SYSTEM, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 50-60 YEAR OLD FEMALE PATIENT UNDERWENT A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING MAPPING PHASE, A CARDIAC TAMPONADE WAS DETECTED. REMAINDER OF PROCEDURE WAS ABORTED. THERE IS NO INFORMATION REGARDING INTERVENTIONS. PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED. PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE ATYPICAL RVOT ANATOMY. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. IT WAS NOTED THAT THE INJURY WAS SECONDARY TO HIGH FORCE EXERTED BY THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER IN THE RVOT. IT WAS ALSO NOTED THAT THE PHYSICIAN WAS MADE AWARE OF THE HIGH FORCE READINGS VIA THE CARTO AND VIA VERBAL NOTIFICATIONS. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. A ST. JUDE MEDICAL/ABBOTT AGILIS SHEATH WAS USED. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, AS THE INJURY DID NOT OCCUR DURING ABLATION. IRRIGATED CATHETER FLOW WAS SET AT 2 ML/MIN DURING MAPPING. PATIENT DID NOT RECEIVE ANTICOAGULANT DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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. FORCE VISUALIZATION FEATURES INCLUDED GRAPH, DASHBOARD, AND VECTOR. THERE WERE NO ADDITIONAL FILTERS USED WITH THE VISITAG. SINCE THIS ADVERSE EVENT REQUIRED EXTENDED HOSPITALIZATION, IT IS MDR REPORTABLE. THE ¿FORCE HIGH¿ ISSUE WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL RISK THAT FORCE HIGH COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN THE PATIENT¿S STATE OF HEALTH WAS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323660 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNKNOWN 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L