BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCAR

    MDR report key: 7571541 · Received June 5, 2018

    Report

    Report Number
    2529252-2018-00003
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    May 22, 2018
    Report Date
    July 17, 2018
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K011727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OUTCOMES ATTRIBUTED TO ADVERSE EVENTS: HOSPITALIZATION-PROLONGED. DATE OF THIS REPORT: 07/17/2018. MODEL # FND-020-01. 510K NUMBER IS K011727.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE LOT # OF THE DEVICE WAS NOT PROVIDED AND NO PHOTOS WERE TAKEN OF THE DEVICE.

    Description of Event or Problem · 1

    "A ST. JUDE SHEATH AND - PROBABLY - BWI TRANSSEPTAL NEEDLEWERE USED DURING AN AFIB PROCEDURE. PUNCTURE CARRIED OUT TOO HIGH, AORTA WAS HIT. NEVERTHELESS, PRESSURE OF THE PATIENT WAS STABLE. CASE WAS CANCELED. LOT # NOT AVAILABLE. AT THIS POINT, NO FURTHER INFORMATION AVAILABLE". A CORONARY CUSP WAS INJURED AND PROLONGATION OF HOSPITALIZATION WAS REQUIRED. THE AORTIC VALVE WAS REPLACED. THE PROCEDURE WAS NOT RESCHEDULED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412160 TROCAR TRANSSEPTAL NEEDLE/TROCAR DYB MERIT MEDICAL SYSTEMS, INC. FND-020-01

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R SJM SHEATH