BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 4725039 · Received April 23, 2015

    Report

    Report Number
    2029046-2015-00122
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    May 1, 2013
    Report Date
    April 1, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. BWI CONCOMITANT PRODUCTS USED: PRODUCT NAME: LASSO 2550, US CATALOG #: UNKNOWN, LOT#: UNKNOWN; PRODUCT NAME: CARTO®3 SYSTEM, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. NON-BWI PRODUCTS USED: NIOBE®II RMNS (STEREOTAXIS), DEFLECTABLE QUADRIPOLAR CATHETER 5 MM INTERELEC-TRODE SPACING; XTREM; ELA MEDICAL, (B)(4); NAVIGANT 2.1;STEREOTAXIS INC., (B)(4). (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. FROM THE ARTICLE - 1 PATIENT EXPERIENCED SEVERE SYMPTOMATIC PULMONARY STENOSIS REQUIRING STENTING IN THE PVI ALONE GROUP; TITLE: REMOTE-CONTROLLED MAGNETIC PULMONARY VEIN ISOLATION COMBINED WITH SUPERIOR VENA CAVA ISOLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: A PROSPECTIVE RANDOMIZED STUDY OBJECTIVES: THIS PROSPECTIVE, RANDOMIZED STUDY SOUGHT TO INVESTIGATE THE EFFICACY OF ADDITIONAL SUPERIOR VENA CAVA ISOLATION (SVCI) COMBINED WITH PULMONARY VEIN ISOLATION (PVI) IN SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION (PAF) PATIENTS REFERRED FOR ABLATION. FROM NOVEMBER 2011 TO MAY 2013, RADIOFREQUENCY ABLATION (RFA) WAS PERFORMED REMOTELY USING A CARTO® 3 SYSTEM IN PATIENTS RANDOMIZED TO UNDERGO PVI PULMONARY VEIN ISOLATION FOR SYMPTOMATIC DRUG-REFRACTORY PAROXYSMAL ATRIAL FIBRILLATION (PAF), WITH (PVI + SVCI GROUP) OR WITHOUT (PVI ALONE GROUP) SVCI. PVI AND SVCI WERE CONFIRMED BY SPIRAL CATHETER RECORDING DURING ABLATION. PROCEDURAL DATA, COMPLICATIONS AND FREEDOM FROM ATRIAL TACHYCARDIA (AT) AND ATRIAL FIBRILLATION (AF) WERE ASSESSED. ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE: 1 PATIENT EXPERIENCED TRANSIENT ISCHEMIC ATTACK WITH COMPLETE RECOVERY IN THE PVI ALONE GROUP; 1 PATIENT EXPERIENCED TRANSIENT PHRENIC NERVE PALSY IN THE PVI + SVCI GROUP; 1 PATIENT EXPERIENCED PHRENIC NERVE INJURY WITH PARTIAL RECOVERY IN THE PVI + SVCI GROUP. THERE ARE NO DEATH EVENTS AND DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. BWI PRODUCTS REPORTED IN THE ARTICLE: NON-FLUOROSCOPIC NAVIGATION SYSTEM (CARTO®3 SYSTEM), LASSO CATHETER AND THERMOCOOL NAVISTAR RMT CATHETER OTHER COMPANIES DEVICES : NIOBE®II RMNS (STEREOTAXIS), DEFLECTABLE QUADRIPOLAR CATHETER 5 MM INTERELEC-TRODE SPACING; XTREM; ELA MEDICAL, (B)(4); NAVIGANT 2.1;STEREOTAXIS INC., ST. LOUIS, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269875 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1266-01-S UNKNOWN_D-1266-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S