BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCLE C SILICONE CATHETER KIT

    MDR report key: 276602 · Received May 9, 2000

    Report

    Report Number
    1056436-2000-00090
    Event Type
    Injury
    Date Received
    May 9, 2000
    Date of Event
    April 12, 2000
    Report Date
    April 13, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/ HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 04/13/2000, THE INTERNATIONAL DISTRIBUTOR INFORMED THE MFR'S INTERNATIONAL REP OF THE FOLLOWING: THE DISTRIBUTOR RECEIVED AN E-MAIL FROM A NEPHROLOGIST. THE E-MAIL STATES THAT THE NEPHROLOGIST WANTED TO REPORT A VERY SERIOUS ADVERSE EVENT WITH THE PRODUCT IN QUESTION. IT GOES ON TO STATE THAT MD INSERTED THIS CATHETER ON 08/09/1999, IN ONE OF THEIR DIALYSIS PTS. THE PROCEDURE WAS UNCOMPLICATED. PT HAD A RELATIVELY UNEVENTFUL DIALYSIS PERIOD EXCEPT FOR ABOUT 3-4 PERIODS OF FLOW PROBLEMS THAT WERE SOLVED WITH LOCAL UROKINASE INSTILLATION (10,000IU/ML) FOR 15 MINUTES. ON REMOVAL OF THE CATHETER ON 04/12/2000, THE LAST 1.5 CM OF THE CATHETER TIP WAS MISSING. THE REMOVAL WAS UNEVENTFUL. MD & STAFF DID NOT HAVE TO PULL HARD AND THE PT EXPERIENCED NO COMPLAINTS. A CHEST X-RAY MADE AFTER REMOVAL SHOWED THE TIP OF THE CATHETER IN THE PERIPHERAL PULMONARY VASCULAR BED OF THE LEFT LUNG WITHOUT ANY PERI-TIP INFILTRATION. THERE HAS BEEN NO MANIPULATION OF THE CATHETER TIP DURING THE PERIOD IT WAS IN PLACE, SO MD & STAFF HAVE TO CONCLUDE IT MUST HAVE BEEN A SPONTANEOUS FRACTURE. MD CONSIDERS THIS A VERY SERIOUS PROBLEM AND MD IS VERY CONCERNED ABOUT USING THIS CATHETER ANYMORE AND WHAT TO DO WITH THE PTS THAT HAVE SUCH A CATHETER IN SITU. THE CATHETER IN QUESTION IS AVAILABLE FOR FURTHER RESEARCH. HOPE TO HEAR FROM YOU SOON. ON 04/21/2000, THE MFR RECEIVED A FAX FROM THE MFR'S DIRECTOR, INTERNATIONAL OPERATIONS THAT STATES THE FOLLOWING: MFR'S DIRECTOR HAS VISITED THE IMPLANTING DOCTOR RELATED TO THIS COMPLAINT OF A BROKEN CATHETER. THE DEVICE WAS IMPLANTED IN 1999, IN THE RIGHT JUGULAR OF A PT. NO X-RAYS WERE TAKEN BETWEEN THIS CONTROL AND THE REMOVAL. BESIDES, A FEW PERIODS OF FLOW PROBLEMS (SOLVED WITH UROKINASE), THE CATHETER FUNCTIONED WELL. THE LAST PERIOD OF FLOW PROBLEM WAS THE END OF JANUARY. WHEN THE CATHETER WAS REMOVED (NO NEED ANYMORE) WITHOUT ANY PROBLEM, THE DOCTOR NOTICED THE TIP (VENOUS OUTLET) WAS MISSING. THERE IS NO INDICATION IF THIS HAPPENED WHEN EXPLANTING OR EARLIER. THE PT DID NOT HAVE ANY CLINICAL SIGNS. X-RAYS WERE TAKEN WHEN THE MISSING PART WAS NOTICED AND THE TIP OF THE CATHETER WAS FOUND IN A LUNG VESSEL. THE TIP WAS NOT REMOVED AND SINCE THERE ARE NO CLINICAL SIGNS OF PROBLEMS, THERE IS AT THIS MOMENT NO INTENTION TO REMOVE THIS PART. THE DOCTOR WILL TAKE SOME PICTURES OF THE CATHETER AND AS SOON AS THIS IS DONE DOCTOR WILL TRANSFER THE CATHETER TO CO FOR FURTHER EXAMINATION. THE EXACT LOT NUMBER OF THE DEVICE IN QUESTION WAS NOT KNOWN AT THE TIME OF THE REPORT. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLE C SILICONE CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/ HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention