BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6956659 · Received October 17, 2017

    Report

    Report Number
    2029046-2017-01028
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    September 21, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17667186L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCT: CARTO 3 SYSTEM, MODEL #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THIS EVENT ON (B)(6) 2018. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE. THEREFORE, "PATIENT AGE AT THE TIME OF EVENT", AGE UNIT" AND "SEX" WERE POPULATED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON MAY 4, 2018, BIOSENSE WEBSTER RECEIVED INFORMATION REGARDING THIS CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER INC. EVENT. THIS ADVERSE EVENT WAS INACTIVATED AS IT WAS REMOVED FROM THE DATABASE AS IT WAS ADDED IN ERROR. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED MDR REPORTABLE. HOWEVER, SINCE IT HAS ALREADY BEEN REPORTED TO FDA, ANY ADDITIONAL UPDATES RECEIVED WILL CONTINUE TO BE REPORTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 27, 2017 WHICH UPDATED THE PATIENT CODE FROM ¿PAIN¿ TO ¿PERICARDITIS¿ AND THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SERIOUS. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER INC., DURING AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED PAIN REQUIRING MEDICATION, LAB WORK, CHEST X-RAY (CXR), AND COMPUTED TOMOGRAPHY (CT) OF THE LUNGS AND LEGS. POST-PROCEDURE, THE PATIENT DEVELOPED PAINFUL COUGHING. AN UNSPECIFIED MEDICATION WAS ADMINISTERED, LABS WERE DRAWN, AND CXR AND LUNG/LEG CT WERE PERFORMED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE EVENT. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT 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
    734837 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 17667186L

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization