BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4708677 · Received April 21, 2015

    Report

    Report Number
    2029046-2015-00098
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    April 1, 2012
    Report Date
    March 27, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: 1.CARTO XP SYSTEM MODEL #: UNKNOWN SERIAL #: UNKNOWN, 2. LASSO CATHETER MODEL #: UNKNOWN LOT #: UNKNOWN, 3. NON BWI - 8-FRENCH LONG SHEATH SWARTZ; ST. JUDE MEDICAL. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT AFTER PULMONARY VEIN ISOLATION (PVI) PROCEDURE DEVELOPED AN ASYMPTOMATIC STENOSIS OF LEFT INFERIOR PULMONARY VEIN. PULMONARY VEIN (PV) ANGIOGRAM SHOWED 20-30% STENOSIS. 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: POUCHED MITRAL ISTHMUS IS ASSOCIATED WITH INCOMPLETE LINEAR BLOCK IN ATRIAL FIBRILLATION PATIENT WITH MECHANICAL MITRAL VALVE REPLACEMENT. OBJECTIVES: BETWEEN MARCH 2009 AND APRIL 2012, 29 CONSECUTIVE PATIENTS WHO DEVELOPED SYMPTOMATIC PERSISTENT AF POST MMVR AND REFERRED TO THE INSTITUTION FOR THE INITIAL AF ABLATION WERE PROSPECTIVELY ENROLLED. OTHER ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE: -1 PATIENT HAD RIGHT FEMORAL HEMATOMA WAS OBSERVED IN THE MMVR GROUP, WHICH RECOVERED WITHOUT ANY FURTHER INTERVENTION. THIS EVENT HAS BEEN ASSESSED AS NON-SERIOUS. THERE ARE NO DEATH EVENTS AND DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE 3.5-MM OPEN-IRRIGATED TIP ABLATION CATHETER NAVI-STAR THERMO-COOL MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263399 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 Other