BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6447613 · Received March 30, 2017

    Report

    Report Number
    2029046-2017-00087
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    February 29, 2016
    Report Date
    March 14, 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
    GM
    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 PRODUCTS WERE USED IN THIS STUDY: CARTO MAPPING SYSTEM. OTHER COMPANIES¿ DEVICES WERE USED IN THIS STUDY: COOLPATH DUO ABLATION CATHETER (ST JUDE MEDICAL); SENSEI (HANSEN MEDICAL), ARTISAN SHEATH (HANSEN MEDICAL), INTELLISENSE SOFTWARE (HANSEN MEDICAL), 8.5F SL1 SHEATH (ST. JUDE MEDICAL), NAVX/ENSITETM VELOCITY SYSTEM (ST. JUDE MEDICAL), ESOPHAGEAL TEMPERATURE PROBE (SENSITHERM; ST. JUDE MEDICAL). (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 200 PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION WHO UNDERWENT RADIOFREQUENCY ABLATION. IN 100 PATIENTS, RNS (RN-GROUP) WAS USED FOR CIRCUMFERENTIAL PULMONARY VEIN ISOLATION AND COMPARED TO 100 MANUALLY ABLATED CONTROL PATIENTS (MN-GROUP). AMONG THEM, 1 PATIENT IN THE RN GROUP, ESOPHAGEAL PERFORATION OCCURRED REQUIRING ESOPHAGEAL STENTING. 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: ¿EXPERIENCE MATTERS: LONG-TERM RESULTS OF PULMONARY VEIN ISOLATION USING A ROBOTIC NAVIGATION SYSTEM FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE LONG-TERM RESULTS OF PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION AFTER CIRCUMFERENTIAL PULMONARY VEIN ISOLATION USING ROBOTIC NAVIGATION SYSTEM. IN THE RN-GROUP, 79 PATIENTS WERE ABLATED WITH NAVISTAR/CELSIUS THERMOCOOL (N = 79); 21 PATIENTS WERE ABLATED COOLPATH DUO (ST JUDE MEDICAL; N = 21). IN THE MN-GROUP, ALL PATIENTS WERE ABLATED WITH THE NAVISTAR THERMOCOOL ABLATION CATHETER (N = 100). BWI TAKES CONSERVATIVE APPROACH TO DOCUMENT ALL COMPLICATIONS UNDER NAVISTAR THERMOCOOL ABLATION CATHETER, HOWEVER, CATALOG AND LOT NUMBER IS UNKNOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230719 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 63 YR Life Threatening| R