BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4037314 · Received August 26, 2014

    Report

    Report Number
    2029046-2014-00279
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    January 1, 2013
    Report Date
    August 1, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE; THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THIS IS A RETROSPECTIVE SINGLE-CENTER STUDY. A TOTAL OF 107 PVI PROCEDURES IN 71 PATIENTS WITH PAROXYSMAL (32%), PERSISTENT (38%) AND LONG STANDING PERSISTENT (30%) ATRIAL FIBRILLATION (AF) WERE ANALYZED. THE AIM OF THE STUDY WAS TO EVALUATE A SINGLE CATHETER MAGNETIC NAVIGATION SYSTEM (MNS) APPROACH IN TERMS OF SAFETY AND EFFICACY OVER LONG-TERM. FROM THE REPORT : 1 PATIENT HAD GROIN HEMATOMAS, WHICH DID NOT PROLONG THE STAY IN HOSPITAL. 1 PATIENT HAD TRANSIENT ISCHEMIC ATTACK. RADIOFREQUENCY (RF) CURRENT WAS DELIVERED WITH A 3.5-MM OPEN-IRRIGATED CATHETER WITH POWER SETTINGS OF 30W, TEMPERATURE LIMIT 45 °C, 25¿30 S, STEP SIZE 3 MM MODEL AND CATALOG NUMBER OF ABLATION CATHETERS ARE NOT AVAILABLE. ALSO NON BWI PRODUCTS WERE USED DURING THE PROCEDURE: 1 DECAPOLAR STEERABLE DIAGNOSTIC CATHETER WAS POSITIONED IN THE CORONARY SINUS (6FR, DYNAMIC DECA, C.R. BARD, INC., (B)(4), USA). FLUOROSCOPIC IMAGING WAS PERFORMED IN ALL PATIENTS USING A DIGITAL IMAGING SYSTEM (ARTIS, SIEMENS, INC., (B)(4), USA). FLUOROSCOPICALLY GUIDED TRANSSEPTAL PUNCTURE WAS PERFORMED TO POSITION ONE SHEATH WITHIN THE LEFT ATRIUM (SRO, 8.5FR AND BRK¿ TRANSSEPTAL NEEDLE, ST. JUDEMEDICAL, INC., (B)(4), USA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515984 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR THERMOCOOL UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R