BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5567385 · Received April 11, 2016

    Report

    Report Number
    9673241-2016-00254
    Event Type
    Death
    Date Received
    April 11, 2016
    Date of Event
    December 31, 2014
    Report Date
    March 29, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: LASSO CATHETER, CARTO SYSTEM. (B)(4) THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT IN HF GROUP UNDERWENT RADIOFREQUENCY CATHETER ABLATION AND DIED DUE TO SEPSIS. TITLE: "ELEVATED RED BLOOD CELL DISTRIBUTION WIDTH PREDICTS RECURRENCE AFTER CATHETER ABLATION FOR ATRIAL FIBRILLATION IN PATIENTS WITH HEART FAILURE." THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE ASSOCIATION BETWEEN RDW AND OUTCOMES AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA) FOR AF IN A LARGE SAMPLE. THE STUDY WAS CONDUCTED BETWEEN (B)(6) 2009 AND (B)(6) 2014 IN THIS STUDY. OTHER SERIOUS AND NON-SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE (SERIOUS EVENTS ARE REPORTED TO FDA SEPARATELY): TWO (2) PATIENTS IN HF GROUP DIED DUE TO DECOMPENSATED HF. TWO (2) PATIENTS IN NON-HF GROUP HF HOSPITALIZATIONS. TWO (2) PATIENTS IN NON-HF GROUP STROKES. ONE (1) PATIENT DIED DUE TO CANCER (BWI WILL NOT OPEN COMPLAINT FOR THIS EVENT AS IT IS NOT DEVICE RELATED OR PROCEDURE RELATED). A 3.5-MM TIP, OPEN-IRRIGATED ABLATION CATHETER WAS USED IN THIS STUDY. BWI TAKES CONSERVATIVE APPROACH TO OPEN THIS COMPLAINT UNDER ABLATION CATHETER THERMOCOOL SMARTTOUCH, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. NO CATHETER TYPE IS SPECIFIED FOR EACH PATIENT. SHOULD MORE INFORMATION BE RECEIVED, PRODUCT FOR THIS ADVERSE EVENT WILL BE MODIFIED AS APPROPRIATE. THE AWARENESS DATE FOR THIS COMPLAINT IS 3/22/2016 BECAUSE THE ARTICLE WAS REVIEWED ON 3/22/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222062 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death