BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8430786 · Received March 18, 2019

    Report

    Report Number
    2029046-2019-02832
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    February 19, 2019
    Report Date
    February 19, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION (MRE) COULD BE PERFORMED. CONCOMITANT PRODUCTS: WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY (MODEL# D-1263-04-S, LOT# UNKNOWN); CARTO 3 SYSTEM (MODEL# UNKNOWN, SERIAL# (B)(4)); SOUNDSTAR ECO GE 8F CATHETER (MODEL# M-5723-18, LOT# UNKNOWN); SMARTABLATE GENERATOR (MODEL# UNKNOWN, SERIAL# UNKNOWN); SMARTABLATE PUMP (MODEL# UNKNOWN, SERIAL# UNKNOWN); BRK-1 TRANSSEPTAL NEEDLE (MODEL# UNKNOWN, LOT# UNKNOWN). BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. REPORT 2029046-2019-02834 ARE RELATED TO THIS SAME INCIDENT. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A LEFT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MIGHT HAVE OCCURRED DUE TO THE WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY (CS) MANIPULATION FOR POST ELECTROPHYSIOLOGY STUDY, AS THE EVENT WAS NOTICED WHEN THE PHYSICIAN TRIED TO REPOSITION THE CS CATHETER. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. (BWI) EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK-1 TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE CATHETER IRRIGATION WAS SET AT 2 ML/MIN. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 2MM, 3 SEC, 25% OVER 3G, 2MM TAG SIZE. THE ADDITIONAL FILTER USED WITH THE VISITAG MODULE WAS RESPIRATORY ADJUSTMENT. THE COLOR OPTION USED PROSPECTIVELY WAS TIME. IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED UNDER THE ABLATION AND CORONARY SINUS CATHETERS SINCE THERE¿S NO CLEAR EVIDENCE TO DETERMINE IF CORONARY SINUS CATHETER MANIPULATION CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222327 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R