BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9172455 · Received October 9, 2019

    Report

    Report Number
    2029046-2019-03737
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    June 29, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.  A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30127620L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    THIS EVENT IS ASSOCIATED WITH A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER, INC. IT WAS REPORTED THAT A (B)(6) MALE PATIENT ((B)(6), 183 CM, BMI DERIVED 36.5 KG/M2) UNDERWENT CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED PERICARDITIS AND PERICARDIAL EFFUSION REQUIRING SURGICAL INTERVENTION. ON (B)(6) 2019, THE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND A REPEAT CARDIAC ABLATION PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT REPORTED WITH SYMPTOMS OF PERICARDITIS AND PERICARDIAL EFFUSION REQUIRING SURGICAL INTERVENTION OF A PERICARDIAL WINDOW TO REMOVE AN UNSPECIFIED AMOUNT OF UNSPECIFIED FLUID. INPATIENT HOSPITALIZATION OF 7 DAYS ((B)(6) 2019 ¿ (B)(6) 2019) WAS REQUIRED. UNSPECIFIED MEDICATION WAS ADMINISTERED. PATIENT¿S OUTCOME IS RECOVERED AND RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE, SERIOUS, NOT RELATED TO THE STUDY DEVICE (VISITAG SURPOINT EPU), NOT RELATED TO THE STUDY CATHETERS, PROBABLY RELATED TO THE RE-ABLATION PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, THIS EVENT WAS EXPECTED. NO BIOSENSE WEBSTER, INC. PRODUCT DEFICIENCIES WERE REPORTED. DURING THE PROCEDURE, 81 RADIO FREQUENCY APPLICATIONS WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966004 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30127620L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R