BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER

    MDR report key: 1408019 · Received June 26, 2009

    Report

    Report Number
    2032228-2009-00001
    Event Type
    Injury
    Date Received
    June 26, 2009
    Date of Event
    June 22, 2009
    Report Date
    June 23, 2009
    Manufacturer
    AVALON LABORATORIES, INC.
    Product Code
    DQO
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT USED PER THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN DID NOT USE A GUIDE WIRE TO PLACE THE CATHETER AND NO IMAGING WAS USED FOR ADVANCEMENT, POSITIONING OR PLACEMENT. THE DEVICE DESCRIPTION IN THE IFU SAYS "THE INTRODUCER IS DESIGNED TO FOLLOW A PREPOSITIONED STANDARD 0.038" (0.97MM) GUIDE WIRE (NOT INCLUDED)". IN SECTION 4.0, INSERTION AND PLACEMENT, OF THE IFU THERE IS A WARNING "INCORRECT INSERTION CAN CAUSE DAMAGE TO THE VESSELS AND/OR HEART STRUCTURE." AND A CAUTION "ALWAYS USE THE INTRODUCER (INCLUDED) OVER A 0.038" (0.97MM) GUIDE WIRE (NOT INCLUDED)". THERE ARE TWO CAUTIONS ABOUT USING IMAGING VERIFY THE ADVANCEMENT, POSITIONING, AND PLACEMENT OF THE GUIDE WIRE USING APPROPRIATE IMAGING TECHNOLOGY." AND "VERIFY THE PLACEMENT THE ADVANCEMENT, POSITIONING, AND PLACEMENT OF THE CATHETER USING APPROPRIATE IMAGING TECHNOLOGY." WITHOUT THE USE OF THE GUIDE WIRE AND APPROPRIATE IMAGING TECHNOLOGY THE CORRECT LOCATION OF THE CATHETER AND INTRODUCER COULD NOT BE DETERMINED AND MAY HAVE CAUSED DAMAGE TO THE HEART STRUCTURE. THE CATHETER WAS USED ON THE PT FROM 2009, WHEN IT WAS REMOVED AND THE PT WAS BREATHING UNASSISTED.

    Description of Event or Problem · 1

    A INFANT IN RESPIRATORY ARREST WAS PLACED ON VENO-VENOUS ECMO USING AN AVALON ELITE 13 FR BI-CAVAL CATHETER. IT SEEMED TO GO IN JUST FINE USING THE INTRODUCER ONLY WITHOUT THE USE OF A GUIDEWIRE. THE PT BECAME HYPOTENSIVE AND THE ECHO SHOWED A LARGE PERICARDIAL EFFUSION. A SUBXIPHOID ANGIOCATH WAS PLACED INTO THE PERICARDIAL SPACE TO RELIEVE THE TAMPONADE AND THE ANGIOCATH WAS REPLACED WITH PIGTAIL. BLOOD WAS ASPIRATED AND VOLUME ADDED VIA ECMO. SURGERY WAS PERFORMED TO REPAIR THE HOLE IN THE RIGHT ATRIUM/IVC JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER BI-CAVAL DQO AVALON LABORATORIES, INC. 10013

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Required Intervention