BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPYGLASS ANGIOGRAPHIC CATH. 4F ANGLED PIGTAIL

    MDR report key: 619178 · Received June 22, 2005

    Report

    Report Number
    2182269-2005-00114
    Event Type
    Other
    Date Received
    June 22, 2005
    Date of Event
    May 20, 2005
    Report Date
    June 22, 2005
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE CARDIAC CATHETERIZATION PROCEDURE, THE TIP OF THE 4F SPYGLASS PIGTAIL CATHETER DETACHED WHILE IN THE PT'S AORTA. THE RIGHT AND LEFT HEART CATHETERIZATION PROCEDURE WERE DONE TO EVALUATE THE PT'S MITRAL REGURGITATION, PULMONARY HYPERTENSION, AND ANGINA. THE PT ALSO HAD SEVERE PERIPHERAL VASCULAR DISEASE. THE RIGHT HEART CATHETERIZATION PROCEDURE WAS PERFORMED VIA THE RIGHT FEMORAL VEIN AND THE LEFT HEART CATHETERIZATION WAS PERFORMED VIA THE RIGHT BRACHIAL ARTERY. HEPARIN, DOSE UNK WAS GIVEN DURING THE PROCEDURE. THE 4F SPYGLASS PIGTAIL CATHETER WAS ADVANCED INTO THE PT WITH THE INTENT TO PERFORM VENTRICULOGRAPHY, WHEN THE TIP OF THE CATHETER SEPARATED AND EMBOLIZED TO THE ABDOMINAL AORTA. THE GUIDE WIRE WAS ADVANCED TO THE AREA AND A 6F MULTIPURPOSE GUIDING CATHETER WAS THEN ADVANCED TO THE DETACHED CATHETER TIP. A 7 MILLIMETER AMPLATZ GOOSE NECK MICROSNARE CATHETER WAS ADVANCED AND THE TIP AND WAS REMOVED BY THE CARDIOLOGIST. RESULTS OF THE ANGIOGRAM REVEALED THE ARTHEROSCLEROTIC IRREGULARITY AND 20-30% STENOSIS OF THE DOMINANT RIGHT CORONARY ARTERY AND AORTIC OCCLUSION BELOW THE SUPERIOR MESENTERIO ARTERY WITH RECONSTITUTION AT THE LEVEL OF THE COMMON FEMORAL ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS ANGIOGRAPHIC CATH. 4F ANGLED PIGTAIL SPYGLASS 4F ANGLED PIGTAIL DQO ST. JUDE MEDICAL NA 1074612

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention