BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS ANGIOGRAPHIC CATHETER 4F PIG/155, 110CM

    MDR report key: 512381 · Received February 20, 2004

    Report

    Report Number
    2182269-2004-00030
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    January 22, 2004
    Report Date
    February 20, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING RIGHT CORONARY ANGIOGRAM INJECTIONS, IT APPEARED THE ARTERY SPASMED, CAUSING TOTAL OCCLUSION OF THE DISTAL SEGMENT. THE PT UNDERWENT AN INTERVENTION OF THIS ARTERY. IT WAS AT THAT POINT THE NURSE NOTED NEUROLOGIC DEFICITS, WHICH WERE TREATED WITH MEDICATION; THE SYMPTOMS SEEMED TO IMPROVE. THE SPYGLASS PIGTAIL CATHETER WAS ADVANCED INTO THE LEFT VENTRICLE AFTER USING THE STRAIGHTENER TO INSERT THE CATHETER INTO THE SHEATH. THE MONITORING TECHNOLOGIST NOTED AN AORTIC WAVEFORM AND INFORMED THE PHYSICIAN THE CATHETER WAS NO LONGER IN VENTRICLE. UNDER FLUOROSCOPY, IT WAS NOTED THE DISTAL SEGMENT OF THE CATHETER WAS MISSING; THE CATHETER WAS REMOVED. ATTEMPTS TO LOCATE THE DETACHED SEGMENT UNDER FLUROSCOPY WERE UNSUCCESSFUL. A CT SCAN REVEALED THE DETACHED PORTION WAS ISOLATED IN THE ILIAC ARTERY. THE SEGMENT WAS REMOVED USING A SNARE AND THE PT HAD REPORTEDLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS ANGIOGRAPHIC CATHETER 4F PIG/155, 110CM SPYGLASS 4F, PIG/155 DQO ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 03DA40

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention