BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER 6

    MDR report key: 7246569 · Received February 6, 2018

    Report

    Report Number
    2029046-2018-01116
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    November 6, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER, INC. IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED DIAPHRAGMATIC PARALYSIS (REQUIRING NO MEDICAL OR SURGICAL INTERVENTION INITIALLY), THEN SUBSEQUENT DYSPNEA (REQUIRING MEDICATION). DURING THE PROCEDURE, THE PATIENT DEVELOPED DIAPHRAGMATIC PARALYSIS. THERE WERE NO INTERVENTIONS. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. ISSUE IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 24, THE PATIENT DEVELOPED DYSPNEA. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. ISSUE IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. SINCE THE DIAPHRAGMATIC PARALYSIS ADVERSE EVENT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87938 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER 6 CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention