BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS¿ INTRODUCER, UNKNOWN

    MDR report key: 9980848 · Received April 21, 2020

    Report

    Report Number
    2182269-2020-00037
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    April 21, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF AIR EMBOLISM WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, NO LOT NUMBER WAS PROVIDED SO A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT POSSIBLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED AIR EMBOLISM COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE IRANIAN HEART JOURNAL, TITLED, "CORONARY AND CEREBRAL ARTERY AIR EMBOLISM COMPLICATING TRANS-SEPTAL ACCESSORY PATHWAY ABLATION." BY HAMID FARZAMNIA, MD ET. AL. A (B)(6)-YEAR-OLD WOMAN PRESENTED WITH FREQUENT EPISODES OF PAROXYSMAL PALPITATION AND ELECTROCARDIOGRAPHIC EVIDENCE OF MINIMAL PRE-EXCITATION OF THE LEFT LATERAL ACCESSORY PATHWAY. THE PATIENT UNDERWENT SEPTOSTOMY, WHICH REVEALED AIR BUBBLES IN THE LEFT VENTRICULAR CAVITY. ASPIRATION WAS DONE WITH A PIGTAIL CATHETER VIA THE RETROGRADE AORTIC APPROACH. TRANSIENT ST-ELEVATION IN THE INFERIOR LEADS WAS DEMONSTRATED. LEFT-SIDED HEMIPLEGIA WAS PRESENT AFTER CONSCIOUSNESS, WHICH WAS COMPLETELY RESOLVED AFTER 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445387 AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention