BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

    MDR report key: 902602 · Received August 22, 2007

    Report

    Report Number
    2183460-2007-00012
    Event Type
    Other
    Date Received
    August 22, 2007
    Report Date
    August 17, 2007
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ABSTRACT DESCRIBED REMOVAL OF AIR EMBOLUS FROM RIGHT CORONARY ARTERY USING ANGIOJET. FURTHER INVESTIGATION REVEALED THAT CAUSE OF THE AIR EMBOLUS WAS UNKNOWN, BUT COULD HAVE BEEN DUE TO INADVERTENT AIR INJECTION DURING PROCEDURE OR TO AIR ENTRAINMENT FROM A PARTIALLY OPEN TUOHY-BORST VALVE DUE TO THE COMBINATION OF A PARTIALLY OPEN TUOHY-BORST VALVE BLOCKAGE OF ANTEGRADE BLOOD FLOW BY THE GUIDE CATHETER, AND THE SUCTION OF THE ANGIOJET XMI CATHETER. THE LATTER MECHANISM IS POSSIBLE WITH ANY ASPIRATION DEVICE, INCLUDING THE ANGIOJET. THIS IS THE ONLY KNOWN REPORT OF SUCH AN EVENT. THE AIR EMBOLUS WAS SUCCESSFULLY ASPIRATED BY ACTIVATING THE ANGIOJET XMI CATHETER WITH NO FURTHER SEQUELAE. THE JOURNAL ARTICLE RECOMMENDS "USE OF A GUIDING CATHETER THAT IS NONOCCLUSIVE OR WITH SIDE HOLES TO ENSURE CONTINUOUS BLOOD FLOW FROM CENTRAL AORTA MAY HELP AVOID ENTRAINMENT OF AIR INTO THE CORONARY ARTERY DURING ACTIVATION OF THE ANGIOJET THROMBECTOMY CATHETER. IN THE EVENT OF SUCH A COMPLICATION, THE ANGIOJET CATHETER CAN BE IMPLEMENTED TO ASPIRATE CORONARY AIR EMBOLI." THIS IS A RARE EVENT THAT IS APPROPRIATELY DISCLOSED IN THE MEDICAL LITERATURE. NO FURTHER FOLLOW UP IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    CASE REPORTS: MASSIVE AIR EMBOLUS TREATED WITH RHEOLYTIC THROMBECTOMY. TWO DRS. ABSTRACT: THE INCIDENCE OF AIR EMBOLISM DURING DIAGNOSTIC CARDIAC CATHETERIZATION AND PERCUTANEOUS CORONARY INTERVENTION IS REPORTED AT A RATE OF 0.84% AND 0.24%. ALTHOUGH THERE IS NO OPTIMAL TECHNIQUE TO RESTORE BLOOD FLOW AFTER BLOCKAGE BY AIR EMBOLI, TREATMENT OPTIONS INCLUDE MANUAL ASPIRATION OR FORCEFULLY INJECTING SALINE, WITH AUXILIARY SUPPORTIVE MEASURES LIKE 100% OXYGEN OR AN INTRA-AORTIC BALLOON PUMP. THE ANGIOJET (POSSIS MEDICAL, INC., MINNEAPOLIS, MINNESOTA) DEVICE IS A CATHETER-BASED DEVICE FOR THROMBUS REMOVAL IN WHICH HIGH-VELOCITY SALINE JETS ARE USED TO CREATE A LOCALIZED LOW-PRESSURE ZONE AT THE DISTAL CATHETER TIP (BERNOULLI EFFECT), RESULTING IN THE MACERATION AND REMOVAL OF THROMBUS THROUGH AN EXHAUST LUMEN. THE USE OF RHEOLYTIC THROMBECTOMY HAS BEEN STUDIED IN THROMBUS-CONTAINING NATIVE CORONARY ARTERIES AS WELL AS SAPHENOUS VEIN GRAFT LESIONS. WE REPORT A CASE OF A MASSIVE AIR EMBOLUS THAT OCCURRED AFTER ACTIVATION OF AN ANGIOJET CATHETER IN A THROMBUS-LADEN RIGHT CORONARY ARTERY (RCA). THE ANGIOJET CATHETER WAS THEN UTILIZED TO EFFECTIVELY ASPIRATE THE AIR EMBOLUS WITH RESTORATION OF CORONARY BLOOD FLOW. USE OF A GUIDING CATHETER THAT IS NONOCCLUSIVE OR WITH SIDE HOLES TO ENSURE CONTINUOUS BLOOD FLOW FROM THE CENTRAL AORTA MAY HELP AVOID ENTRAINMENT OF AIR INTO THE CORONARY ARTERY DURING ACTIVATION OF THE ANGIOJET THROMBECTOMY CATHETER. TO OUR KNOWLEDGE, THIS IS THE FIRST REPORTED CASE OF SUCH A POTENTIAL COMPLICATION. IN THE EVENT OF SUCH A COMPLICATION, THE ANGIOJET CAN BE IMPLEMENTED TO ASPIRATE A CORONARY AIR EMBOLUS J INVASIVE CARDIOL 2007; 19:E182-E184.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM AJ SYSTEM DXE POSSIS MEDICAL, INC. AJ SYSTEM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other