BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS KIT.

    MDR report key: 20511136 · Received October 22, 2024

    Report

    Report Number
    1125782-2024-00005
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MERIT MEDICAL RICHMOND
    Product Code
    PXU
    UDI-DI
    00884450015278
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION TO INCLUDE: *** SECTION A: PATIENT INFO RECEIVED/UPDATED. SECTION B: [X] ALLEGED PRODUCT PROBLEM CHECKED. SECTION B5 - ADDITIONAL INFORMATION UPDATED. CORRECTIONS: SECTION B: EVENT DATE CHANGED TO OCT 14TH 2024. SECTION B.2 EVENT / PATIENT DEATH DATE CHANGED TO: (B)(6) 2024. CODE A UPDATED TO REPLACE 2993 AND INCLUDE 1544, 1670. CODE G UPDATED TO INCLUDE: 3038.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    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. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE IDENTIFIED. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND.

    Description of Event or Problem · 0

    THE GUIDEWIRE IN USE DURING PCI THAT LED TO THE PERICARDIAL EFFUSION WAS AN .014 W /HYDROPHILIC TIP. THE PHYSICIAN STATES THAT DUE TO THE THE STIFFNESS AND CURVE OF THE PC DRAINAGE CATHETER, THE PC CATHETER ALSO CONTRIBUTED TO THE LACERATION OF THE PERICARDIUM. PERICARDIAL ACCESS WAS VIA THE SUBXIPHOID TECHNIQUE, UNDER US GUIDANCE. PROCEDURAL ACCESS WAS VIA THE RIGHT RADIAL ARTERY AND THE PATIENT'S TIME OF DEATH WAS 6:00 PM ON (B)(6) 2024.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT AN EMERGENCY PERICARDIOCENTESIS PROCEDURE WAS REQUIRED ON A MALE PATIENT, DUE TO AN INTERVENTIONAL GUIDEWIRE PERFORATION AT THE DISTAL CIRCUMFLEX ARTERY, DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE ALLEGED DISTAL CX PERFORATION WAS TREATED BUT, THE PATIENT CONTINUED TO SHOW SIGNS OF A PERICARDIAL EFFUSION THAT LED TO HEMOPERICARDIUM AND CARDIAC TAMPONADE. THE PATIENT UNDERWENT AN EMERGENT THORACOTOMY WHERE THE PERICARDIOCENTESIS DRAINAGE CATHETER WAS IDENTIFIED AT THE INFEROLATERAL WALL OF THE PATIENT'S LEFT VENTRICLE. THE PATIENT LATER EXPIRED DESPITE ALL ATTEMPTS TO TREAT THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31476 PERICARDIOCENTESIS KIT. FLUID DRAINAGE TRAY PXU MERIT MEDICAL RICHMOND T2876373 00884450015278

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death ASAHI SION BLACK .014 W /HYDROPHILIC TIP.| INTERVENTIONAL BALLOON| INTERVENTIONAL GUIDWIRE