BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9471122 · Received December 15, 2019

    Report

    Report Number
    2029046-2019-04000
    Event Type
    Injury
    Date Received
    December 15, 2019
    Date of Event
    November 19, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009194
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 MANUFACTURE RECORD EVALUATION (MRE) REVIEW COULD BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, POST USE OF AND BIOSENSE WEBSTER INC. (BWI) PRODUCT, PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAM (ECHO). THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS AND 400 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED. A STEAM POP OCCURRED DURING THE CASE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THERE WERE NO ERROR MESSAGES DISPLAYED ON BWI EQUIPMENT. THE IRRIGATION SETTINGS WERE STANDARD FOR STSF. FORCE VISUALIZATION INCLUDED GRAPH, DASHBOARD, VECTOR, AND VISITAG. THE VISITAG SETTINGS WERE STABILITY 2.5MM/ 3 SEC, FORCE OVER TIME AT 25, 3G OF FORCE, 2MM TAG SIZE AND FORCE TIME INTERVAL OPTION COLOR OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265774 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009194

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R