BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8135809 · Received December 5, 2018

    Report

    Report Number
    2029046-2018-02405
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 7, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCT - ST. JUDE MEDICAL BRK1 TRANSSEPTAL NEEDLE 2. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL AGILIS SHEATH MEDIUM CULR 13.5 FR OUTER DIAMETER 3. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL 8.5FR INNER DIAMETER SHEATH 4. BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM CATALOG #: UNKNOWN SERIAL #: UNKNOWN MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, WHILE ABLATING THE LEFT VENTRICLE PAPILLARY MUSCLE A SMALL EFFUSION WAS NOTICED ON INTRACARDIAC ULTRASOUND. SINCE THE SIGNALS HAD INDICATED THAT THE ARRHYTHMIA CHANGED TO EPICARDIUM, THE PHYSICIAN DECIDED TO MOVE TO THE EPICARDIUM AND CONTINUED TO BURN THE PREMATURE VENTRICULAR CONTRACTIONS. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE FLUID FROM THE PERICARDIUM. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES AND NO SIGN OF FURTHER EFFUSION PROGRESSION. THE PATIENT STAYED AN OVERNIGHT FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE PATIENT EVENT IS THAT IT WAS PROCEDURE AND PATIENT ANATOMY RELATED. THE PATIENT HAD A DIFFICULT ANATOMY AND HISTORY OF SARCOIDOSIS. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK1 TRANSSEPTAL NEEDLE. A ST. JUDE AGILIS SHEATH MEDIUM CULR 13.5 FR OUTER DIAMETER AND 8.5FR INNER DIAMETER SHEATH WAS USED DURING THE PROCEDURE. THE GENERATOR WAS USED IN POWER CONTROL MODE, TEMPERATURE AND POWER CUT OFFS WERE LEFT AT GENERATOR DEFAULT SETTINGS FOR THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE POWER DID NOT TITRATE DURING THE ABLATION, THE PHYSICIAN CAME ON ABLATION AT A CERTAIN WATTAGE AND STAYED AT THE SAME WATTAGE. THE OVERALL TIME FOR ABLATION IS UNKNOWN. THE CATHETER IRRIGATION WAS SET WITHIN DEFAULT SETTINGS FOR THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR >=30W AT 8 ML/MIN, FOR 31W AND HIGHER AT 15 ML/MIN. ANTICOAGULANT WAS ADMINISTERED DURING THE PROCEDURE WITH AN ACTIVATED CLOTTING TIME (ACT) MAINTAINED ABOVE 250 SECONDS. THE CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER AND IT WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973794 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R