BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_NAVISTAR THERMOCOOL

    MDR report key: 10215126 · Received June 30, 2020

    Report

    Report Number
    2029046-2020-00795
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    January 1, 2018
    Report Date
    June 10, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBER 2029046-2020-00794 IS RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED ¿EFFICACY OF HYBRID THERAPY USING PRIOR ADMINISTRATION OF BEPRIDIL HYDROCHLORIDE AND CRYOBALLOON ABLATION IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION.¿ 3 PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION WHO UNDERWENT ATRIAL FIBRILLATION CATHETER ABLATION FROM NON-RECURRENCE GROUP EXPERIENCED PHRENIC NERVE INJURY. PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE EFFICACY OF PRETREATMENT WITH BEPRIDIL PRIOR TO CRYOBALLOON ABLATION (CBA) WITH RESPECT TO CLINICAL OUTCOMES IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION. METHODS: FROM NOVEMBER 2015 TO APRIL 2018 65 CONSECUTIVE PATIENTS WITH PEAF WHO UNDERWENT CBA FOLLOWING PRETREATMENT WITH BEPRIDIL HYDROCHLORIDE (BEPRIDIL). ELECTRICAL CARDIOVERSION WAS ADDITIONALLY PERFORMED IN CASES INVOLVING THE FAILURE OF PHARMACOLOGICAL SINUS RESTORATION BEFORE CBA. THE PRIMARY ENDPOINT WAS SURVIVAL FREE FROM ATRIAL TACHYARRHYTHMIA AT THE ONE-YEAR FOLLOW-UP, AND THE SECONDARY ENDPOINTS WERE CHANGES IN P-WAVE MORPHOLOGY AND LEFT ATRIUM DIAMETER (LAD) BEFORE CRYOBALLOON ABLATION WERE RETROSPECTIVELY ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679898 UNK_NAVISTAR THERMOCOOL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other