BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6409689 · Received March 16, 2017

    Report

    Report Number
    2029046-2017-00073
    Event Type
    Death
    Date Received
    March 16, 2017
    Date of Event
    December 31, 2011
    Report Date
    March 1, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. (B)(4). THE PRODUCT IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 509 CONSECUTIVE PATIENTS SUFFERING FROM SYMPTOMATIC DRUG-REFRACTORY AF UNDERWENT PULMONARY VEIN ANTRUM ISOLATION FROM 2005 TO 2011. AMONG THEM, 1 PATIENT DIED SUDDENLY 5 WEEKS AFTER THE PROCEDURE. AUTOPSY REVEALED A PERI-EPICARDITIS WITH SIGNIFICANT PERICARDIAL EFFUSION. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿FIVE-YEAR EFFICACY OF PULMONARY VEIN ANTRUM ISOLATION AS A PRIMARY ABLATION STRATEGY FOR ATRIAL FIBRILLATION: A SINGLE-CENTRE COHORT STUDY¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE LONG-TERM EFFICACY OF PVAI AS A PRIMARY ABLATION STRATEGY IN ALL PATIENTS INDEPENDENTLY FROM THE TYPE OF AF. ALSO, PREDICTORS FOR ARRHYTHMIA RECURRENCE WILL BE ASSESSED. SUSPECT DEVICE IS THERMOCOOL IRRIGATED TIP ABLATION CATHETER, HOWEVER CATALOG OR LOT NUMBER ARE UNKNOWN. FOR DOCUMENTATION PURPOSE, COMPLAINT IS OPENED UNDER NAVISTAR THERMOCOOL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191877 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death