BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 12372483 · Received August 26, 2021

    Report

    Report Number
    2029046-2021-01397
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    January 8, 2021
    Report Date
    August 16, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). UNABLE TO ATTACH LITERATURE ARTICLE AS THE ELECTRONIC FILE IS TOO LARGE TO SUBMIT. INVESTIGATION SUMMARY : SINCE THE PRODUCT HAS NOT BEEN RETURNED, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE LITERATURE ARTICLE TITLED, "IS THERE AN ASSOCIATION BETWEEN EPICARDIAL ADIPOSE TISSUE AND OUTCOMES AFTER PAROXYSMAL ATRIAL FIBRILLATION CATHETER ABLATION" WRITTEN BY NÉFISSA HAMMACHE, HUGO PEGORER-SFES, KARIM BENALI, ISABELLE MAGNIN POULL, ARNAUD OLIVIER, MATHIEU ECHIVARD, NATHALIE PACE, DAMIEN MINOIS, NICOLAS SADOUL, DAMIEN MANDRY, JEAN MARC SELLAL, AND CHRISTIAN DE CHILLOU PUBLISHED BY JOURNAL OF CLINICAL MEDICINE ? J. CLIN. MED. 2021, 10, 3037. HTTPS://DOI.ORG/10.3390/ JCM10143037 PUBLISHED 8 JULY 2021 WAS REVIEWED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH IRRIGATED TIP CF SENSING ABLATION CATHETER. OTHER BIOSENSE PRODUCTS UTILIZED IN STUDY: LASSO, CARTO SOUND MAPPING SYSTEM NON-BIOSENSE PRODUCTS UTILIZED IN STUDY: FLEXIBILITY ABLATION CATHETER, ENSITE NAVX SYSTEM, XTREM STEERABLE QUADRIPOLAR CATHETER (USED IN CORONARY SINUS FOR ELECTRO ANATOMICAL MAPPING REFERENCE). EXACT QUANTITIES OF INVOLVED PRODUCTS CANNOT BE ACCURATELY DETERMINED AS THE ARTICLE DOES NOT SPECIFY WHICH SPECIFIC ABLATION CATHETERS ARE ASSOCIATED WITH EACH ADVERSE EVENT. THE FOLLOWING ADVERSE EVENT(S) WERE REPORTED IN THIS PUBLICATION: FIVE ABORTED PROCEDURES DUE TO INTRA-PROCEDURAL TAMPONADE (INTERVENTION NOT DISCUSSED IN ARTICLE). ONE STROKE (INTERVENTION NOT DISCUSSED IN ARTICLE). INTOLERABLE PAIN (INTERVENTION NOT DISCUSSED IN ARTICLE). OBJECTIVE: THE AIM OF THIS STUDY WAS TO EVALUATE THE PREDICTIVE VALUE OF CLINICAL, ECHOCARDIOGRAPHIC, BIOLOGICAL PARAMETERS AND EAT CHARACTERISTICS MEASURED BY COMPUTED TOMOGRAPHY SCAN (CT-SCAN) ON AF RECURRENCE IN PAF PATIENTS AFTER A FIRST RADIOFREQUENCY (RF) PVI. METHODS: THIS MONOCENTRIC RETROSPECTIVE STUDY INCLUDED ALL PATIENTS UNDERGOING FIRST-TIME RF PAF ABLATION AT THE NANCY UNIVERSITY HOSPITAL BETWEEN MARCH 2015 AND DECEMBER 2018 WITH ONE-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271864 UNK_THERMOCOOL SF NAV THERMOCOOL CATHETER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other