BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 17399140 · Received July 26, 2023

    Report

    Report Number
    9616662-2023-00010
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 13, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    PXU
    UDI-DI
    00884450013465
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT AT THE END OF A CRYOTHERAPY PROCEDURE FOR ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION, THE PATIENT WAS UNRESPONSIVE TO SIMPLE COMMANDS. THE CLINICAL TEAM SUSPECTED CARDIAC TAMPONADE. CPR WAS ADMINISTERED AND THE PATIENT WAS INTUBATED. TWO ATTEMPTS TO PERFORM A PERICARDIOCENTESIS WERE ATTEMPTED BY THE ATTENDING PHYSICIAN. FIRST ATTEMPT: PERICARDIAL PUNCTURE IS UNSUCCESSFULLY ATTEMPTED WITH THE 18G PINK NEEDLE. THE PRACTITIONER STATES THAT THE NEEDLE MAY BE CLOGGED; IT WAS IMPOSSIBLE TO PULL BACK ON THE PLUNGER OF THE SYRINGE. SECOND ATTEMPT: PERICARDIAL PUNCTURE IS ATTEMPTED WITH A PINK SPINOCAN 18GG 88MM NEEDLE REFERENCE 4501390 FROM BBRAUN. THIS ATTEMPT WAS SUCCESSFUL, AND THE PROCEDURE WAS COMPLETED WITH 90 ML'S OF BLOOD REMOVED FROM THE PATIENT'S PERICARDIAL SACK. THE SAME SYRINGE WAS USED WITH BOTH NEEDLES. THE PATIENT'S VITAL SIGNS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839727 PERICARDIOCENTESIS KIT PERICARDIOCENTESIS CATHETER KIT PXU MERIT MEDICAL SYSTEMS INC. PC803EU/A 00884450013465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening