BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6556274 · Received May 9, 2017

    Report

    Report Number
    9673241-2017-00365
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    March 27, 2017
    Report Date
    April 26, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION WAS RECEIVED ON (B)(6)2019 FOR THE PATIENT CONSEQUENCES OF PULMONARY EMBOLISM AND PERICARDIAL EFFUSION. BOTH THESE ISSUES WERE RESOLVED WITHOUT SEQUELAE. MANUFACTURER¿S REFERENCE NUMBER:(B)(4).

    Additional Manufacturer Narrative · 0

    ORIGINALLY FOR THE PATIENT CONSEQUENCE OF PERICARDIAL EFFUSION, IT WAS REPORTED THAT THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2018 STATING THAT THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY. LEGACY MANUFACTURER'S REF. NO: (B)(4). MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018. THE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE. CONCOMITANT PRODUCTS USED WERE THE FOLLOWING: 1.NON BIOSENSE WEBSTER, INC. - AGILIS SHEATH 2.STOCKERT GENERATOR US CATALOG #: UNKNOWN SERIAL #: UNKNOWN 3.LASSO CATHETER US CATALOG #: UNKNOWN LOT #: UNKNOWN THEREFORE, POPULATED CONCOMITANT MED PRODUCTS" FIELD. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    DURING A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER, INC., IT WAS REPORTED THAT A 69 YEAR OLD MALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL SF CATHETER AND SUFFERED A PULMONARY EMBOLISM (REQUIRING AN UNSPECIFIED MEDICATION) AND A PERICARDIAL EFFUSION (REQUIRING AN UNSPECIFIED MEDICATION). CARDIOVASCULAR MEDICAL HISTORY INCLUDES CORONARY DISEASE, SYSTEMIC HYPERTENSION, LEFT ANTERIOR DESCENDING (LAD) STENT, AND TYPE II DIABETES MELLITUS. ON POST-PROCEDURE DAY 28, THE PATIENT PRESENTED TO THE FACILITY WITH COMPLAINT OF COUGH. CHEST COMPUTED TOMOGRAPHY (CT) REVEALED BILATERAL PULMONARY EMBOLISMS. INTERVENTION WAS MEDICATION (UNSPECIFIED). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS ONGOING AND IMPROVED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE, NOT DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 28, THE PATIENT WAS DIAGNOSED WITH A PERICARDIAL EFFUSION. INTERVENTION WAS MEDICATION (UNSPECIFIED). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY PROCEDURE-RELATED. NO DEVICE DEFICIENCIES WERE REPORTED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17580679L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (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 WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL SF CATHETER AND SUFFERED A PULMONARY EMBOLISM (REQUIRING AN UNSPECIFIED MEDICATION) AND A PERICARDIAL EFFUSION (REQUIRING AN UNSPECIFIED MEDICATION). CARDIOVASCULAR MEDICAL HISTORY INCLUDES CORONARY DISEASE, SYSTEMIC HYPERTENSION, LEFT ANTERIOR DESCENDING (LAD) STENT, AND TYPE II DIABETES MELLITUS. ON POST-PROCEDURE DAY 28, THE PATIENT PRESENTED TO THE FACILITY WITH COMPLAINT OF COUGH. CHEST COMPUTED TOMOGRAPHY (CT) REVEALED BILATERAL PULMONARY EMBOLISMS. INTERVENTION WAS MEDICATION (UNSPECIFIED). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS ONGOING AND IMPROVED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE, NOT DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 28, THE PATIENT WAS DIAGNOSED WITH A PERICARDIAL EFFUSION. INTERVENTION WAS MEDICATION (UNSPECIFIED). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY PROCEDURE-RELATED, NO DEVICE DEFICIENCIES WERE REPORTED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION 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
    336978 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-02-SI 17580679L

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R SEE H10