BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIVAC WITH STRAIGHT CATHETER

    MDR report key: 510724 · Received February 6, 2004

    Report

    Report Number
    2939222-2004-00005
    Event Type
    Injury
    Date Received
    February 6, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 9, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS PUNCTURED DURING AN ANGIOPLASTY PROCEDURE, RESULTING IN TAMPONADE. THE EP TECHNOLOGIES PERIVAC KIT WAS USED TO PERFORM A PERICARDIOCENTESIS. THE PHYSICIAN SUTURED THE STRAIGHT DRAINAGE CATHETER FROM THE KIT TO THE THORACIC WALL. PT STABILIZED AFTER RECEIVING A FEW UNITS OF BLOOD. TWO HOURS LATER, THE PT WAS PLACED ON THEIR SIDE FOR AN ULTRASOUND. AT THAT POINT THE DRAINAGE CATHETER WAS REPORTED TO HAVE PUNCTURED THE RIGHT VENTRICLE. THE RIGHT VENTRICLE PUNCTURE WAS SUTURED WITH A THORACOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIVAC WITH STRAIGHT CATHETER PERICARDIOCENTESIS KIT KDQ EP TECHNOLOGIES, INC. 4314 917331

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R