BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR? ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3853180 · Received June 6, 2014

    Report

    Report Number
    2029046-2014-00157
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    September 1, 2012
    Report Date
    June 5, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: CARTO3 SYSTEM (MODEL # UNKNOWN, SERIAL # UNKNOWN) . (B)(4).

    Description of Event or Problem · 1

    ARTICLE TITLE: HIGH-DENSITY SUBSTRATE-GUIDED VENTRICULAR TACHYCARDIA ABLATION: ROLE OF ACTIVATION MAPPING IN AN ATTEMPT TO IMPROVE PROCEDURAL EFFECTIVENESS: PER A REPORT IN THE JOURNAL OF HEART RHYTHM SOCIETY, (VOL 10, PP. 1850-1858, DECEMBER 2013), A (B)(4) STUDY WAS CONDUCTED ON 126 PATIENTS ENROLLED FROM (B)(6) 2010 TO (B)(6) 2011, BY (B)(4),MD OF THE (B)(6) CENTRE,(B)(6)., TO INVESTIGATE WHETHER CONVENTIONAL AMAP FURTHER CONTRIBUTES TO THE IDENTIFICATION OF CRITICAL SITES OF VENTRICULAR TACHYCARDIA (VT) REENTRY AND WHETHER THIS TRANSLATES INTO A MORE EFFECTIVE ABLATION OUTCOME IN A COHORT OF PATIENTS UNDERGOING VT ABLATION. PATIENTS WERE FOLLOWED UP FOR 1 YEAR. FROM THE REPORT THERE WERE 12 SERIOUS ADVERSE EVENTS WHICH REQUIRED INTERVENTION OR HOSPITALIZATION (3 ARTERIOVENOUS FISTULA, 3 PERICARDIAL EFFUSIONS, 5 HEMODYNAMIC DETERIORATION AND 1 TRANSIENT ISCHEMIC ATTACK (TIA). PER THE ARTICLE, OTHER NON-SERIOUS AE¿S WERE ALSO REPORTED: 1 PROLONGED BLEEDING AFTER EPICARDIAL ABLATION (WHICH IS AN OFF-LABEL USE), 3 HEMODYNAMIC DETERIORATION. THESE EVENTS ARE NOT KNOWN TO HAVE REQUIRED INTERVENTION/TREATMENT NOR EXTENDED HOSPITALIZATION STAY. THERE ARE 6 UNRELATED DEATH EVENTS REPORTED AT 1-YEAR FOLLOW-UP AND NO DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. PER THE AUTHOR'S ASSESSMENT THESE DEATHS (WORSENING HEART FAILURE IN 4 PATIENTS AND INTRACTABLE ELECTRICAL STORM IN 2 PATIENTS) WERE NOT DIRECTLY RELATED TO PROCEDURE OR DEVICE AND THEREFORE THEY ARE NOT CONSIDERED REPORTABLE UNDER BIOSENSE WEBSTER PRODUCTS. THIS COMPLAINT WAS CREATED UNDER THE NAVISTAR THERMOCOOL, AS THE MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL/ NAVISTAR THERMOCOOL SF. THE ABOVE MENTIONED EVENTS ARE CURRENTLY UNDER INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, WE WILL UPDATE INFORMATION IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332492 NAVISTAR? ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR TC UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R