BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7284056 · Received February 20, 2018

    Report

    Report Number
    2029046-2018-01217
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 22, 2018
    Report Date
    January 22, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 24, 2018 ON THE EVENT. AN URGENT PERICARDIOCENTESIS WAS REQUIRED TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO BODY STRUCTURE / FUNCTION. EXTENDED HOSPITALIZATION WAS ALSO REQUIRED. THEREFORE, UPDATED ¿HOSPITALIZATION INITIAL/PROLONGED¿. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Additional Manufacturer Narrative · 1

    INITIALLY IT WAS REPORTED THAT THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS ¿DEFINITELY INVESTIGATIONAL DEVICE-RELATED¿. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 8, 2018 WHICH UPDATED THIS INFORMATION TO ¿NOT INVESTIGATIONAL DEVICE-RELATED¿. THEY ALSO STATED THAT THE ISSUE RESOLVED WITHOUT SEQUELAE. (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 A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, A CARDIAC TAMPONADE WAS DETECTED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, DEFINITELY INVESTIGATIONAL DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO PRECLUDE 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
    126397 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNKNOWN 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R