BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2030404-2018-00067

    MDR report key: 7887021 · Received September 18, 2018

    Report

    Report Number
    2030404-2018-00067
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 18, 2018
    PMA / PMN Number
    K133853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DISSECTION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING AN ABLATION PROCEDURE, WHEN ATTEMPTING TO PLACE THE VIEWFLEX CATHETER THROUGH THE LEFT FEMORAL VEIN, WHEN ADVANCING THE CATHETER THROUGH A 10CM 10FR SHEATH, INSERTION DIFFICULTY WAS NOTED AT THE AREA OF THE UPPER INFERIOR VENA CAVA. THE CATHETER WAS WITHDRAWN AND THE SHEATH WAS REPLACED WITH A 40CM 10FR SHEATH AND THE CATHETER WAS ADVANCED WITHOUT DIFFICULTY. THE CASE PROGRESSED WITHOUT PATIENT ISSUES. FOLLOWING THE PROCEDURE IN THE POST OP RECOVERY UNITY, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A CAT SCAN REVEALED A TEAR IN THE INFERIOR VENA CAVA. ANTICOAGULATION WAS REVERSED AND PAIN MEDICATION WAS ADMINISTERED. THE PATIENT REMAINED STABLE AND WAS FOLLOWED IN THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH AN ABBOTT DEVICE.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization