BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCARDIOCENTESIS KIT.STERILE

    MDR report key: 12174195 · Received July 15, 2021

    Report

    Report Number
    1125782-2021-00001
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    June 29, 2021
    Report Date
    June 30, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS
    Product Code
    PXU
    UDI-DI
    00884450054017
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A LOT NUMBER WAS REPORTED, AND A REVIEW OF THE MANUFACTURING HISTORY RECORD IS IN PROGRESS. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT A SCHEDULED PERICARDIOCENTESIS PROCEDURE IN THE EP LAB FOR AN ELDERLY FEMALE PATIENT DIAGNOSED WITH CARDIAC TAMPONADE WAS SUCCESSFULLY COMPLETED. THE ACCESS APPROACH WAS "APICAL" AND WAS COMPLETED UNDER FLUOROSCOPY. BOTH THE GUIDEWIRE AND DILATOR WITHIN THE KIT WERE USED DURING THE PROCEDURE TO ACQUIRE PC CATHETER ACCESS. NO ANATOMICAL VARIATIONS WERE EXPERIENCED OR DIFFICULTIES IN INFILTRATING THE PATIENT'S PERICARDIUM. THE ACCOUNT ALLEGES THAT DURING THE PC CATHETER REMOVAL, RESISTANCE WAS EXPERIENCED BY THE PHYSICIAN. ADDITIONAL INTERVENTIONS TO REMOVE THE CATHETER SAFELY WERE INITIATED HOWEVER, THE TIP OF THE PIG TAIL DRAINAGE CATHETER DETACHED, JUST DISTAL TO THE MARKER BAND WITHIN THE PATIENT'S PERICARDIUM. CT SURGERY ASSISTED IN TRYING TO REMOVE THE FOREIGN BODY FROM THE PATIENT. A VASCULAR SNARE DEVICE WAS UTILIZED UNSUCCESSFULLY. A DRAINAGE TUBE WAS PLACED, AND THE PATIENT WAS TRANSFERRED TO ICU FOR THORACIC SURGERY CONSULTATION. IT IS LIKELY SURGICAL INTERVENTION [STERNOTOMY] WILL BE NEEDED IF THE PATIENT CAN TOLERATE THE PROCEDURE. ALL PARTS OF THE PC CATHETER HAVE BEEN DISCARDED. NOTHING AVAILABLE TO RETURN FOR INVESTIGATION. THE PATIENT HAS SINCE THEN RECOVERED AND HAS BEEN DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074458 PERCARDIOCENTESIS KIT.STERILE CUSTOM KIT PXU MERIT MEDICAL SYSTEMS 00884450054017

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R