BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS¿ INTRODUCER, UNKNOWN

    MDR report key: 8633636 · Received May 22, 2019

    Report

    Report Number
    2182269-2019-00067
    Event Type
    Injury
    Date Received
    May 22, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED FEMORAL ARTERIOVENOUS FISTULA COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY IN AN ARTICLE TITLED ¿CATHETER ABLATION OF ATRIAL FIBRILLATION WITH NON-FLUOROSCOPIC CATHETER VISUALIZATION¿A PROSPECTIVE RANDOMIZED COMPARISON" BY SASCHA ROLF, KATHARINA SCHOENE, ET AL., 18 SEPTEMBER 2018. THIS IS THE FIRST STUDY OF PROSPECTIVE RANDOMIZED COMPARISON OF FLUOROSCOPY NEEDS, PROCEDURE TIMES, AND COMPLICATIONS IN ATRIAL FIBRILLATION (AF) CATHETER ABLATION WITH OR WITHOUT ADDITIONAL USE OF NON-FLUOROSCOPIC CATHETER VISUALIZATION (NFCV). BETWEEN MARCH 2013 AND SEPTEMBER 2014, A TOTAL OF 80 PATIENTS WERE PROSPECTIVELY RANDOMIZED IN A 1:1 FASHION TO EITHER AF CATHETER ABLATION WITH ELECTRO-ANATOMICAL MAPPING SYSTEM ALONE (ENSITE NAVX¿) OR WITH THE ADDITION OF THE NFCV TECHNOLOGY. ALL PROCEDURES WERE PERFORMED IN THE SAME LAB USING THE SAME ABLATION CATHETER TIP TECHNOLOGY AND THE SAME MAPPING AND ABLATION STRATEGIES. ISOLATION OF ALL FOUR PULMONARY VEINS BY CIRCUMFERENTIAL ABLATION AS CONFIRMED BY A CIRCULAR MAPPING CATHETER WAS ACHIEVED IN ALL PATIENTS. ONE PATIENT IN THE FIRST COHORT EXPERIENCED A FEMORAL ARTERIOVENOUS FISTULA, WHICH DID NOT REQUIRE SURGICAL TREATMENT. NO OTHER COMPLICATIONS OCCURRED. (DOI: 10.1007/S10840-018-0446-8).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424525 AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER DYB ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other