BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8445025 · Received March 22, 2019

    Report

    Report Number
    2029046-2019-02866
    Event Type
    Death
    Date Received
    March 22, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/22/2019, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LOT # OF THE CONCOMITANT MED PRODUCT IS 300100134L. CONCOMITANT MED PRODUCT FIELD IS TO BE UPDATED FROM "VISITAG SURPOINT EPU (US CATALOG # D160801, LOT # UNKNOWN)" TO "VISITAG SURPOINT EPU (US CATALOG # D160801, LOT # 300100134L)" MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 5/22/2019, BIONSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE DATE OF DEATH WAS (B)(6) 2019. AS SUCH, DATE OF DEATH HAS BEEN POPULATED. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 4/28/2020, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION WHICH INDICATED THAT THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS EXPECTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30130877L NUMBER, AND NO NON-CONFORMANCES WERE FOUND DURING THE REVIEW. CONCOMITANT MEDICAL PRODUCTS: VISITAG SURPOINT EPU (US CATALOG # D160801, LOT # UNKNOWN). MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER INC. IT WAS REPORTED THAT AN (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED LEFT MIDDLE CEREBRAL ARTERY (MCA) STROKE (REQUIRING A CEREBRAL ANGIOGRAM WITH MECHANICAL THROMBECTOMY) AND DEATH. POST-PROCEDURE, THE PATIENT SUFFERED LEFT MIDDLE CEREBRAL ARTERY (MCA) STROKE. A CEREBRAL ANGIOGRAM WITH MECHANICAL THROMBECTOMY WAS PERFORMED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. AT AN UNSPECIFIED POINT, THE PATIENT EXPIRED. THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS SEVERE IN SEVERITY, SERIOUS, UNRELATED TO THE STUDY DEVICE (VISITAG SURPOINT EPU), UNRELATED TO NON-INVESTIGATIONAL BWI DEVICES, POSSIBLY STUDY CATHETER RELATED, AND PROBABLE INDEX PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236696 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D134805 30130877L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| R