BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-CATH INTRODUCER

    MDR report key: 14787260 · Received June 23, 2022

    Report

    Report Number
    3005334138-2022-00375
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    June 29, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED TAMPONADE / EFFUSION REMAINS UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN CARDIOLOGY JOURNAL 2022, VOL. 29, NO. 2, "ATRIAL LOW VOLTAGE AREAS: A COMPARISON BETWEEN ATRIAL FIBRILLATION AND SINUS RHYTHM" ; ET AL: ANA ANDRÉS LAHUERTA. ATRIAL FIBROSIS CAN PROMOTE ATRIAL FIBRILLATION (AF). ELECTROANATOMIC MAPPING (EAM) CAN PROVIDE INFORMATION REGARDING LOCAL VOLTAGE ABNORMALITIES THAT MAY BE USED AS A SURROGATE MARKER FOR FIBROSIS. SPECIFIC VOLTAGE CUT-OFF VALUES HAVE BEEN REPRODUCED ACCURATELY TO IDENTIFY FIBROSIS IN THE VENTRICLES, BUT THESE VALUES ARE NOT WELL DEFINED IN ATRIAL TISSUE THIS STUDY IS A PROSPECTIVE SINGLE-CENTER STUDY. PATIENTS WITH PERSISTENT AF REFERRED FOR ABLATION WERE INCLUDED. EAM WAS PERFORMED BEFORE ABLATION. WE RECORDED BIPOLAR SIGNALS, FIRST IN AF AND LATER IN SINUS RHYTHM (SR). TWO THRESHOLDS DELIMITED LOW-VOLTAGE AREAS (LVA), 0.5 AND 0.3 MV. WE COMPARED LVA EXTENSION BETWEEN MAPS IN SR AND AF IN EACH PATIENT. RESULTS: A TOTAL OF 23 PATIENTS WERE INCLUDED IN THE STUDY. ONE COMPLICATION OF CARDIAC TAMPONADE OCCURRED WHICH WAS SOLVED BY PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401001 FAST-CATH INTRODUCER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention