BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 366002 · Received December 14, 2001

    Report

    Report Number
    2024168-2001-00405
    Event Type
    Injury
    Date Received
    December 14, 2001
    Date of Event
    November 14, 2001
    Report Date
    November 14, 2001
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE IN THE RIGHT CORONARY ARTERY, THE GUIDING CATHETER WAS IN PLACE IN THE ARTERY ALONG WITH THE "RHV". DURING THE PURGE OF THE "RHV", THE BLOOD FLOW RETURN DID NOT OCCUR AND UPON INJECTION OF CONTRAST LIQUID (IODE), AN AIR BUBBLE WENT UP INTO THE CIRCULATORY SYSTEM LEADING TO A CARDIAC ARREST. THE PT WAS RESUSCITATED AND IS ALIVE. IT WAS REPORTED THAT THE VALVE WAS STUCK CLOSED AND THAT WAS THE REASON WHY FLOW RETURN DID NOT OCCUR. IT WAS REPORTED THAT ANOTHER PHYSICIAN, WHO WAS OPERATING WITH THE PRIMARY PHYSICIAN, DID NOT WARN THE PHYSICIAN OF THE NO-RETURN FLOW AND THE PHYSICIAN FLUSHED IODE WHILE THE PURGE WAS NOT PERFORMED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56805 20/30 PRIORITY PACK W/COPILOT ACCESSORY KIT DTL GUIDANT VASCULAR INTERVENTION NA 1091251

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R GUIDE WIRE: BMW, INFLATION DEVICE: PPK 20/30,| RHV: COPILOT.