BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED

    MDR report key: 10643143 · Received October 7, 2020

    Report

    Report Number
    3005334138-2020-00481
    Event Type
    Death
    Date Received
    October 7, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 21, 2020
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 PATIENT DEATH REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REF: 3008452825-2020-00534, 3005334138-2020-00480, 3005334138-2020-00481.DURING A VENTRICULAR TACHYCARDIA (VT) / LEFT VENTRICLE (LV) SUBSTRATE ABLATION PROCEDURE, THE PATIENT EXPIRED. THE PATIENT BECAME HYPOTENSIVE, THE LEFT VENTRICLE WALL MOTION WAS NIL AND INTRACARDIAC ECHOCARDIOGRAPHY CONFIRMED THERE WAS NO EFFUSION PRESENT. BLOOD PRESSURE MEDICATION WAS ADMINISTERED, AND CARDIOPULMONARY RESUSCITATION WAS STARTED. THE LV WAS STRUCTURALLY INTACT CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE LV WALL MOTION NEVER RESUMED, AND THE PATIENT CODED FOR 30-40 MINUTES WITH NO CHANGE AND THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT A CLOT LIKELY TRAVELED DOWN THE CORONARY AND PATIENT HAD A MYOCARDIAL INFARCTION DURING PROCEDURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106178 TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL (AFD-PLYMOUTH)

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death ADVISOR¿ HD GRID CATHETER, SE| AGILIS¿ INTRODUCER| ADVISOR¿ HD GRID CATHETER, SE| AGILIS¿ INTRODUCER