BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8438789 · Received March 20, 2019

    Report

    Report Number
    2029046-2019-02855
    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
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    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

    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. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT BWI 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
    231199 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening