BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7325759 · Received March 8, 2018

    Report

    Report Number
    2029046-2018-01286
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 8, 2018
    Report Date
    February 8, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 PRODUCTS: 1.NON-BIOSENSE WEBSTER, INC.- ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE , 2.NON-BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL 8.5 FRENCH SL2 SHEATH, 3.CARTO 3 SYSTEM, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN, MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT WAS AWAKE AND REPORTED FEELING VERY HOT. PHYSICIAN NOTED INCREASED VAGAL TONE. DURING MAPPING, THE PATIENT BECAME HYPOTENSIVE WITH SYSTOLIC BLOOD PRESSURE DECREASING FROM 130 MMHG TO 65 MMHG. A SMALL PERICARDIAL EFFUSION WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS YIELDED 100 ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR OBSERVATION. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. IT WAS NOTED THAT IT IS UNKNOWN IF THE INJURY OCCURRED DURING MAPPING OR ABLATION. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THAT ABLATION WAS BEING PERFORMED BETWEEN THE MITRAL VALVE AND THE MYOCARDIUM, 1 ¿ 1.5 CM FROM THE PERICARDIAL SPACE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. IT WAS NOTED THAT THERE WERE NO ERRORS OR ISSUES REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL 8.5 FRENCH SL2 SHEATH. GENERATOR WAS SET ON POWER CONTROL MODE AT 30-50 WATTS WITH CUT-OFF AT 50 WATTS AND TEMPERATURE CUT-OFF AT 42 DEGREES CELSIUS. GENERATOR SETTINGS AT THE TIME OF INJURY INCLUDED POWER AT 40 ¿ 50 WATTS, STANDARD TEMPERATURE RANGE, AND IMPEDANCE OF 115-150 OHMS. CONTACT FORCES RANGED FROM APPROXIMATELY 12-15 GRAMS, WITH INTERMITTENT INCREASES UP TO 40 GRAMS DURING THE RESPIRATORY CYCLE. POWER WAS NOT TITRATED DURING ABLATION. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME AT THE SITE OF INJURY, AS THE SITE OF INJURY IS UNKNOWN. LAST ABLATION CYCLE TIME WAS APPROXIMATELY 60 SECONDS. IRRIGATED CATHETER FLOW WAS SET AT 15 ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME (ACT) MAINTAINED AT 350 SECONDS OR GREATER. 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167803 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNKNOWN 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R