BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9209064 · Received October 18, 2019

    Report

    Report Number
    2029046-2019-03738
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 18, 2018
    Report Date
    September 12, 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 30064216L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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) YEAR-OLD MALE PATIENT (90KG, 170CM) UNDERWENT CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED DYSPNEA AND CHEST PAIN REQUIRING SURGICAL INTERVENTION. ON (B)(6) 2019, ONE-YEAR POST-PROCEDURE, THE PATIENT SUFFERED DYSPNEA AND IT PROGRESSED INTO CHEST PAIN. INTERVENTION INCLUDED LEFT HEART CATHETERIZATION (LHC) AND A STENT TO LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO ADDITIONAL HOSPITALIZATION WAS REQUIRED. THE PATIENT'S OUTCOME IS RESOLVED/RECOVERED. NO BIOSENSE WEBSTER, INC. PRODUCT DEFICIENCIES WERE REPORTED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE, SERIOUS, NOT RELATED TO STUDY DEVICE, NOT RELATED TO BIOSENSE WEBSTER, INC. NON-INVESTIGATIONAL DEVICES, NOT RELATED TO THE STUDY PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, THIS EVENT WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004178 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30064216L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention