BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4120822 · Received September 26, 2014

    Report

    Report Number
    2029046-2014-00327
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    November 1, 2012
    Report Date
    August 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE PRODUCT IS NOT AVAILABLE, THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT: PENTARAY CATHETER, US CATALOG # UNKNOWN, LOT # UNKNOWN; PRODUCT: LASSO CATHETER, US CATALOG # UNKNOWN, LOT # UNKNOWN; PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    ARTICLE TITLE: ADMINISTRATION OF ISOPROTERENOL AND ADENOSINE TO GUIDE SUPPLEMENTAL ABLATION AFTER PULMONARY VEIN ANTRUM ISOLATION. PER A REPORT IN THE JOURNAL OF J CARDIOVASC ELECTROPHYSIOL, VOL. 24, PP. 1199-1206, NOVEMBER 2013, A SINGLE-CENTER STUDY WAS CONDUCTED ON 388 PATIENTS, BY ELAYI OF THE DEPARTMENT OF CARDIOVASCULAR MEDICINE, UNIVERSITY OF KENTUCKY, LEXINGTON, KENTUCKY, USA ET AL., TO ASSESS THE EFFECT OF ADMINISTRATION OF ISUPREL/ADENOSINE AFTER PULMONARY VEIN ANTRUM ISOLATION ON ABLATION SUCCESS RATE. MEAN FOLLOW-UP TIME OF 22 ± 8 MONTHS. FROM THE REPORT THERE WERE 7 SERIOUS ADVERSE EVENTS: TWO PATIENTS HAD TRANSIENT PHRENIC NERVE PARALYSIS. THREE PATIENTS HAD PERICARDIAL EFFUSIONS REQUIRING DRAINAGE. TWO PATIENTS HAD A TRANSIENT ISCHEMIC ATTACK (TIA). PER THE ARTICLE, OTHER NON-SERIOUS AE¿S WERE ALSO REPORTED: EIGHT PATIENTS HAD A MAJOR HEMATOMA. EIGHT PATIENTS HAD ASYMPTOMATIC MODERATE PV STENOSIS. SIX PATIENTS HAD PERICARDIAL EFFUSION. THESE EVENTS ARE NOT KNOWN TO HAVE REQUIRED INTERVENTION/TREATMENT NOR EXTENDED HOSPITALIZATION STAY. IF ADDITIONAL INFORMATION IS RECEIVED, WE WILL UPDATE INFORMATION IN A SUPPLEMENTAL REPORT. THERE ARE NO DEATH EVENTS AND NO DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL. CONCOMITANT PRODUCTS: PENTARAY CATHETER, LASSO CATHETER AND CARTO3 MAPPING SYSTEM WERE USED IN SOME OF THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601757 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 63 YR Life Threatening