BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 5239536 · Received November 20, 2015

    Report

    Report Number
    2029046-2015-00268
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    December 31, 2014
    Report Date
    November 3, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: DECAPOLAR CORONARY SINUS CATHETER, LASSO CIRCULAR MAPPING CATHETER, CARTO MAPPING SYSTEM OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: BIPOLAR RF CLAMP (ATRICURE INC), LINEAR PEN DEVICE (ISOLATOR PEN AND COOLRAIL, ATRICURE), LEFT ATRIAL APPENDAGE CLIP (ATRICLIP, ATRICURE), 8-F SHEATH (SL0, ST. JUDE MEDICAL). (B)(4). METHODS: NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (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 PATIENT WITH LONGSTANDING PERSISTENT ATRIAL FIBRILLATION UNDERWENT RADIOFREQUENCY ABLATION USING NAVISTAR THERMOCOOL CATHETER AND DEVELOPED A LARGE POSTOPERATIVE EPICARDIAL HEMATOMA (11X6 CM) AROUND THE RIGHT ATRIUM WHICH REQUIRED SURGICAL DRAINAGE. THE AUTHOR ASSESSED THAT THIS ADVERSE EVENT MIGHT DUE TO THE SYSTEMIC HEPARINIZATION DURING THE ENDOCARDIAL ABLATION. THE PATIENT ALSO EXHIBITED A NON-SIGNIFICANT STENOSIS OF LEFT INFERIOR PULMONARY VEIN (LIPV) (50%). 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: "REPEAT PROCEDURES AFTER HYBRID THORACOSCOPIC ABLATION IN THE SETTING OF LONG STANDING PERSISTENT ATRIAL FIBRILLATION: LECTROPHYSIOLOGICAL FINDINGS AND 2 YEAR CLINICAL OUTCOME." THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE ELECTROPHYSIOLOGICAL (EP) FINDINGS AND CLINICAL OUTCOME IN PATIENTS THAT UNDERWENT A REPEAT PROCEDURE AFTER HYBRID AF ABLATION FOR RECURRENT ATRIAL TACHYARRHYTHMIAS. ALL PATIENTS HAVING UNDERGONE REPEAT PERCUTANEOUS RF ABLATION BETWEEN (B)(6) 2010 AND (B)(6) 2014. SUSPECT DEVICE IS NAVISTAR THERMOCOOL ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE WHICH ARE REPORTED TO FDA SEPARATELY: ONE (1) PATIENT PNEUMOTHORAX. ONE (1) PATIENT FEMORAL PSEUDOANEURYSM. TWO (2) PATIENTS PNEUMONIA. THE AWARENESS DATE FOR THIS COMPLAINT IS 11/3/2015 BECAUSE THE ARTICLE WAS REVIEWED ON 11/3/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769186 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 61 YR Life Threatening| R