BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAMIC MANIFOLD

    MDR report key: 1060689 · Received June 6, 2008

    Report

    Report Number
    MW5007297
    Event Type
    Other
    Date Received
    June 6, 2008
    Date of Event
    May 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    CH MEDICAL PRODUCT & SERVICES
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION, THE PHYSICIAN WAS UNABLE TO ASPIRATE BLOOD OR PUSH OPTIRAY 350 CONTRAST THROUGH THE PIGTAIL CATHETER, WHICH WAS IN PATIENT'S LEFT VENTRICLE. PATIENT COMPLAINED OF HEADACHE AND WARM SENSATION AT THIS TIME. THE PIGTAIL CATHETER WAS REMOVED. A SECOND PIGTAIL CATHETER WAS INSERTED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. PATIENT'S HEADACHE AND WARM SENSATION RESOLVED. NO HARM TO PT. ONCE THE PROCEDURE WAS COMPLETED, THE PHYSICIAN PASSED A WIRE THROUGH LUMEN OF THE PIGTAIL CATHETER WHICH HAD NOT FUNCTIONED PROPERLY. (IT SHOULD BE NOTED THAT PRIOR TO INTRODUCTION INTO THE PATIENT, THIS CATHETER HAD BEEN FLUSHED AND FOUND TO BE PATENT). THE WIRE MET OBSTRUCTION IN THE DISTAL END. THE DISTAL END WAS CUT OPEN TO REVEAL TWO FOREIGN BODIES LODGED IN THE SIDE PORTS OF THE PIGTAIL CATHETER. THESE FOREIGN BODIES WERE CLEAR IN COLOR; HARD AND SMOOTH IN TEXTURE, AND APPROXIMATELY 1MM IN DIAMETER. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CHEST PAIN/ANGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC MANIFOLD MORSE ANGIOGRAPHIC MANIFOLD, MEDIUM PRESSURE DTL CH MEDICAL PRODUCT & SERVICES REF 70038303 1245060
    2 LIEBE-FLARSHEIM INJECTOR ANGIOMAT ILLUMENA LILNDEN LUER SYRINGE WITH HANDI-FIL IZQ CH MEDICAL PRODUCT & SERVICES REF 9000103 8060109

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other