BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPARIN FLUSH, HEPARIN FLUSH

    MDR report key: 1201827 · Received October 17, 2008

    Report

    Report Number
    1321116-2008-00003
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 16, 2008
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE TEMPORAL AND PHYSICAL LINK BETWEEN THE EVENT OCCURRENCE AND THE FLUSH DEVICE, THE EVENT OF CATHETER THROMBOSIS IS LIKELY RELATED TO THE DEVICE. THE EVENT OF CORONARY ARTERY STENOSIS, HOWEVER, IS UNLIKELY RELATED TO THE DEVICE ITSELF AND MORE LIKELY A FUNCTION OF THE UNDERLYING DISEASE FOR WHICH THE DEVICE IS INDICATED.

    Description of Event or Problem · 1

    CORONARY ARTERY STENOSIS, CATHETER THROMBOSIS. CASE (B) (4) IS A SPONTANEOUS CASE REPORT RECEIVED FROM A HEALTH PROFESSIONAL WHICH REFERS TO A (B) (6) MALE PATIENT. THE REPORT WAS FORWARDED FROM (B) (4) ON BEHALF OF THE MEDICINE COMPANY. THE PATIENT'S MEDICAL HISTORY INCLUDED CHEST PAIN AND A PREVIOUS PROCEDURE 1.5 YEARS AGO, TYPE NOT SPECIFIED. A CO-SUSPECT DRUG FOR THE EVENT WAS ANGIOMAX (BIVALIRUDIN), MANUFACTURED BY THE MEDICINE COMPANY. CONCOMITANT MEDICATION ALSO INCLUDED EPTIFIBATIDE AND ACETYLSALICYLIC ACID (ASA). THE PATIENT'S DRUG ALLERGY HISTORY WAS NOT REPORTED. ON 09/17/2008 AT 08:00, THE PATIENT WAS ADMINISTERED 0.75 MG/KG INTRAVENOUS BOLUS OF BIVALIRUDIN FOLLOWED BY A 1.75 MG/KG/HOUR INFUSION FROM 08:00 TO 11:45 FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT ALSO RECEIVED ACETYLSALICYLIC ACID (ASA) PRIOR TO THE PROCEDURE. AN ACTIVATED COAGULATION TIME (ACT) WAS 290 SECONDS AND TWO DRUG ELUTING STENTS WERE DEPLOYED IN THE RIGHT CORONARY ARTERY. AFTER THE STENTS WERE DEPLOYED, RESIDUAL STENOSIS WAS NOTED AND PRESSURE IN THE EQUIPMENT WAS DAMPENING. AN ATTEMPT WAS MADE TO FLUSH USING HEPARIN AND SALINE BUT IT WAS UNSUCCESSFUL. A GIANT CLOT CAME OUT OF THE CATHETER AFTER ASPIRATING THE "LUEY", WHICH IS THE Y SPLITTER, AND IT WAS NOTED TO BE FULL OF CLOT. THERE WERE NO VISIBLE CLOTS IN THE PATIENT AND THE PATIENT REMAINED FINE THROUGHOUT THE ENTIRE PROCEDURE. A BOLUS OF EPTIFIBATIDE WAS GIVEN FOLLOWED BY INFUSION, ALL EQUIPMENT WAS CHANGED, AND THE PROCEDURE WAS CONTINUED. THE CATHETER CLOTTED OFF AGAIN APPROXIMATELY AN HOUR LATER. AGAIN THERE WERE NO VISIBLE CLOTS IN THE PATIENT. THE PROCEDURE WAS COMPLETED AT 11:45 AND THE PATIENT WAS DOING FINE. THE PHYSICIAN'S ASSESSMENT OF THE EVENT RELATIONSHIP TO BIVALIRUDIN WAS UNLIKELY RELATED. ADDITIONALLY, THE PHYSICIAN FELT IT WAS PROBABLY RELATED TO THE HEPARIN/SALINE FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN FLUSH, HEPARIN FLUSH UNK NZW UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other