BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 5731116 · Received June 16, 2016

    Report

    Report Number
    2029046-2016-00065
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    July 31, 2014
    Report Date
    May 27, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE INCIDENCE, POSSIBLE RISK FACTORS, MANAGEMENT, AND HOSPITAL OUTCOMES OF CEREBROVASCULAR EVENTS FOLLOWING CATHETER ABLATION OF ATRIAL FIBRILLATION. ALL PATIENTS WHO UNDERWENT AN AF ABLATION PROCEDURE FROM JULY 2007 TO JULY 2014 WERE INCLUDED IN THIS STUDY. OTHER 8 SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE AND ARE REPORTED TO FDA SEPARATELY. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO MAPPING SYSTEM. OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: ENSITE NAVX SYSTEM (ST JUDE MEDICAL, USA), 3DING SYSTEM (SICHUAN JINJIANG ELECTRONIC SCIENCE AND TECHNOLOGY CO., LTD, CHINA). CONTACT OFFICE AND MANUFACTURING SITE SHOULD REFLECT: (B)(4). (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE (B)(6) MALE PATIENT (CASE 7) UNDERWENT RADIOFREQUENCY CATHETER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION AND SUFFERED CARDIAC TAMPONADE, INTRA-OPERATIVE ISCHAEMIC STROKE AND SUBSEQUENT INTRACRANIAL HAEMORRHAGE WHICH REQUIRED CEREBRAL ANGIOGRAPHY AND DECOMPRESSIVE CRANIECTOMY. THE SECOND TRANSSEPTAL PUNCTURE RESULTED IN A DISSECTION OF THE LEFT SUPERIOR PULMONARY VEIN THAT PROPAGATED INTO THE PERICARDIAL SPACE. THE PATIENT DEVELOPED ACUTE CARDIAC TAMPONADE WITH THE NEED FOR SUBSEQUENT PERICARDIAL DRAINAGE. INTRAVENOUS PROTAMINE 50 MG WAS SIMULTANEOUSLY ADMINISTRATED. SURGICAL INTERVENTION WAS PREVENTED, BUT THE ABLATION PROCEDURE HAD TO BE ABORTED BECAUSE OF THE OCCURRENCE OF SUBSEQUENT CEREBROVASCULAR EVENTS. THE SYMPTOM OF EVENT WAS STUPOR. LESION LOCATION WAS RIGHT FRONTAL LOBE, PARIETAL LOBE, AND TEMPORAL LOBE. THE PATIENT HAD NO MAJOR MEDICAL HISTORY. NONE WAS USED FOR PRE-PROCEDURAL ANTICOAGULATION AND MINIMAL ACT DURING PROCEDURES WAS 153S. RHYTHM AT THE ONSET OF PROCEDURE WAS SINUS RHYTHM AND RHYTHM OF ADVERSE EVENT ONSET WAS SINUS RHYTHM. THE AUTHOR COMMENTED THAT THE LIKELIHOOD OF BWI DEVICES CITED IN THE ARTICLE RELATED TO THE REPORTED PATIENT CONSEQUENCES WAS VERY LOW; THE ADVERSE EVENTS WERE MAINLY RELATED TO PERIOPERATIVE ANTICOAGULATION; THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE PROCEDURE RELATED AND PATIENT CONDITION RELATED. 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: "INCIDENCE AND OUTCOMES OF CEREBROVASCULAR EVENTS COMPLICATING CATHETER ABLATION FOR ATRIAL FIBRILLATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385126 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 52 YR Hospitalization| L| R