BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7743685 · Received August 2, 2018

    Report

    Report Number
    2029046-2018-01897
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 9, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 30030747L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: 1.NON-BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL ABBOT SL1. 2.CARTO 3 SYSTEM, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING AND CATHETER MANIPULATION, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS YIELDED 520CC OF FLUID. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS IMPROVED. PATIENT AGE AND GENDER WERE CITED AS FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT COULD BE RELATED TO THE CATHETER MANIPULATION AND PATIENT¿S AGE. THERE WERE NO ISSUES OR ERRORS REPORTED IN ANY BIOSENSE WEBSTER, INC. PRODUCT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE SHEATH THAT WAS PRESUMABLY USED DURING THE PROCEDURE WAS A ST. JUDE MEDICAL ABBOT SL1. GENERATOR WAS NOT IN USE AS ABLATION WAS NOT PERFORMED AT SITE. THE IRRIGATION FLOW SETTING WAS AT 2ML/MIN DURING MAPPING PHASE. THE PATIENT DID NOT RECEIVED ANTICOAGULANT DURING THE PROCEDURE. THERE¿S NO INFORMATION REGARDING THE SHAFT PROXIMITY INTERFERENCE VALUE. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE 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. THE CARTO 3 DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585703 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30030747L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R