BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCARDIOCENTESIS KIT.STERILE

    MDR report key: 12174199 · Received July 15, 2021

    Report

    Report Number
    1125782-2021-00002
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 27, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS
    Product Code
    PXU
    UDI-DI
    00884450054017
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED AT PATIENT'S BEDSIDE WITHIN THE UNIT FOR SUBACUTE CARDIAC TAMPONADE. THE PHYSICIAN FAILED TO ACQUIRE ACCESS TO THE PATIENT'S PERICARDIUM WITH THE 8.3F PIGTAIL CATHETER. THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE DRAINAGE CATHETER TO THE PERICARDIUM OVER-THE-ACCESS WIRE. THE PHYSICIAN HAD TO USE ADDITIONAL FORCE WITH THE DILATOR/GUIDEWIRE WHICH POSSIBLY RESULTED IN THE PUNCTURE/PERFORATION OF THE PATIENT'S RIGHT VENTRICLE. THE ACCOUNT AGREES THAT AN INADEQUATE NUMBER OF DILATORS WERE AVAILABLE TO PROPERLY DILATE THE PERICARDIUM DUE TO THE FACT THIS PROCEDURE WAS PERFORMED AT PATIENT'S BED SIDE AND NOT IN CATHLAB SETTING. THE PATIENT WAS TRANSFERRED TO SURGICAL UNIT FOR URGENT THORACOTOMY AFTER RIGHT VENTRICULAR PERFORATION. PATIENT WAS DOING WELL TWO WEEKS POST-SURGICAL FOLLOW UP. DEVICE WAS DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION. THE REPORTING NURSE STATES THAT THIS PATIENT HAS A HISTORY OF RADIATION THERAPY TO CHEST THAT WOULD HAVE CAUSED A LOT OF SCAR TISSUE/FIBROUS TISSUE FORMATION RESULTING IN EXTREME DIFFICULTY IN ACQUIRING ACCESS DURING PERICARDIOCENTESIS ATTEMPTS. HISTORICALLY, DIFFICULT ACCESS TO THE PERICARDIUM HAS BEEN A FACTOR WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072045 PERCARDIOCENTESIS KIT.STERILE CUSTOM KIT PXU MERIT MEDICAL SYSTEMS 00884450054017

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R