BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR

    MDR report key: 8438815 · Received March 20, 2019

    Report

    Report Number
    2029046-2019-02852
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 27, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/21/2019, CONFIRMATION WAS RECEIVED FROM THE BIOSENSE WEBSTER INC. CLINICAL ACCOUNT SPECIALIST, THAT IT WAS DISCOVERED THE PATIENT DID NOT HAVE AN ATRIAL ESOPHAGEAL FISTULA. NO PATIENT CONSEQUENCES OCCURRED FROM THIS PROCEDURE. HOWEVER, SINCE THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, BIOSENSE WEBSTER INC. WILL CONTINUE TO REPORT SUPPLEMENTAL MDRS TO FDA AS ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT. PATIENT CODE UPDATED FROM 1862 (FISTULA) TO 2199 (NO CONSEQUENCES OR IMPACT TO PATIENT) DEVICE CODE UPDATED FROM 2993 (ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM) TO 3189 (NO APPARENT ADVERSE EVENT). MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN PRODUCT INFORMATION FOR THE SMARTABLATE GENERATOR SYSTEM USED DURING THIS PROCEDURE, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SINCE THERE IS NO PRODUCT INFORMATION, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING CLARIFICATION OF THE SYSTEM USED IN THIS EVENT, THE COMPLAINT WILL BE REOPEN AND INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO SERIAL NUMBER IS AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: CARTO® 3 SYSTEM (US CATALOG # FG540000, SERIAL # (B)(4)), PENTARAY D CURVE CATHETER (US CATALOG # UNKNOWN, LOT # UNKNOWN), WEBSTER CS UNIDIRECTIONAL F CURVE CATHETER(US CATALOG # UNKNOWN, LOT # UNKNOWN). MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE GENERATOR AND SUFFERED ESOPHAGEAL FISTULA. DURING THE PROCEDURE, THE PATIENT SUFFERED ESOPHAGEAL FISTULA. IT IS UNKNOWN IF MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION, PATIENT¿S OUTCOME OR PHYSICIAN CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS RELATED TO THE SAME EVENT: MFR # 2029046-2019-02852 FOR PRODUCT CODE UNK_SMARTABLATE GENERATOR (SMARTABLATE GENERATOR). MFR # 2029046-2019-02855 PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231649 SMARTABLATE¿ SYSTEM RF GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening