BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6465434 · Received April 6, 2017

    Report

    Report Number
    2029046-2017-00096
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    February 28, 2014
    Report Date
    March 16, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 OR CARTO XP MAPPING SYSTEM, STOCKERT GENERATOR; BIPOLAR RF CLAMP (ATRICURE); BIPOLAR RF PEN OR A LINEAR PEN DEVICE (ISOLATOR PEN AND COOLRAIL); LEFT ATRIAL APPENDAGE (LAA) CLIPPING (ATRICLIP, ATRICURE). (B)(4). THE PRODUCT IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 83 PATIENTS UNDERWENT HYBRID THORACOSCOPIC AND ENDOCARDIAL ABLATION OF PERSISTENT OR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION FROM NOVEMBER 2009 THROUGH FEBRUARY 2014. 52 PATIENTS UNDERWENT SAME-DAY HYBRID ABLATION, WHILE 31 UNDERWENT A STAGED PROCEDURE. AMONG THEM, 6 PATIENTS IN THE SAME-DAY GROUP EXPERIENCED POSTOPERATIVE BLEEDING NECESSITATING TRANSFUSION. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTIONS 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: ¿STAGED VERSUS SIMULTANEOUS THORACOSCOPIC HYBRID ABLATION FOR PERSISTENT ATRIAL FIBRILLATION DOES NOT AFFECT TIME TO RECURRENCE OF ATRIAL ARRHYTHMIA¿. THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE PROCEDURAL DIFFERENCES AND EFFECTS ON AF/AT RECURRENCE AMONG PATIENTS UNDERGOING A SAME-DAY VERSUS A STAGED APPROACH FOR TT HYBRID ABLATION OF PERSISTENT AND LONGSTANDING PERSISTENT ATRIAL FIBRILLATION AT A SINGLE CENTER. AN OPEN IRRIGATED-TIP THERMOCOOL OR THERMOCOOL SF CATHETER WERE USED IN THIS STUDY. FOR DOCUMENTATION PURPOSES, ALL COMPLAINTS WERE OPENED UNDER THE NAVISTAR THERMOCOOL ABLATION CATHETER, HOWEVER, CATALOG AND LOT NUMBERS ARE UNKNOWN. SHOULD MORE INFORMATION BE RECEIVED IN THE FUTURE, PRODUCT WILL BE MODIFIED ACCORDINGLY. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250998 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 62 YR Required Intervention