BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX RHEOLYTIC THROMBECTOMY SET

    MDR report key: 871828 · Received June 25, 2007

    Report

    Report Number
    2183460-2007-00004
    Event Type
    Other
    Date Received
    June 25, 2007
    Date of Event
    March 19, 2007
    Report Date
    June 23, 2006
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SERIES OF FOUR EVENTS OCCURRING AT THE SAME INSTITUTION AND WITH THE SAME OPERATOR. PROCEDURE CONSISTED OF AV ACCESS DECLOT USING THROMBOLYTICS, THROMBECTOMY, AND ANGIOPLASTY IN A FEMALE WITH HISTORY OF RENAL FAILURE, DIALYSIS, PREVIOUS SHUNT DECLOT, AND CODEINE ALLERGY. PROCEDURE REPORT INDICATES PTA BALLOON CATHETER INFLATIONS, 125,000 UNITS UROKINASE DELIVERED THROUGH SHEATH, 1 MG TPA DELIVERED THROUGH SHEATH, 19 PASSES OF AVX THROMBECTOMY SET OPERATED FOR 500 SECONDS, FURTHER PTA BALLOON CATHETER INFLATIONS, FOGARTY BALLOON TREATMENT, LEMAITRE EMBOLECTOMY CATHETER TREATMENT, FURTHER PTA BALLOON CATHETER INFLATIONS, 21.8 MINUTES OF FLUORO, 85 ML OF VISIPAQUE CONTRAST AND 3 HOUR 4 MINUTE PROCEDURE TIME. PATIENT REPORTED TO ER WITHIN 48 HOURS WITH SEVERE ABDOMINAL PAIN AND ELEVATED LIVER ENZYMES. POSSIS REPRESENTATIVES DISCUSSED ALL EVENTS WITH PHYSICIAN AND STRESSED THE NEED TO LIMIT RUN TIMES, ESPECIALLY IN FLOWING BLOOD FIELD. HEMOLYSIS IS A KNOWN COMPLICATION OF ANGIOJET USE, AND THE PRODUCT INSTRUCTIONS FOR USE RECOMMENDS "THAT HEMOLYSIS INDICATORS IN THE BLOOD BE MONITORED IF CATHETER OPERATION IN A FLOWING BLOOD FIELD EXCEEDS 5 MINUTES, TOTAL CATHETER OPERATION TIME EXCEEDS 10 MINUTES OR IN PATIENTS WHO CANNOT TOLERATE TRANSIENT HEMOLYSIS." THIS TYPE OF EVENT IS RARE WITH ANGIOJET USE, BUT IS POSSIBLY RELATED TO EXCESSIVE HEMOLYSIS DUE TO PROLONGED OPERATION IN A FLOWING BLOOD FIELD.

    Description of Event or Problem · 1

    AV DECLOT RUN FOR 500 CC. PT HAD GREATLY ELEVATED LIVER ENZYMES AFTER COMING INTO ER WITH SEVERE ABDOMINAL PAIN WITHIN 48 HOURS OF AJ. PT ALSO EXPOSED TO UK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX RHEOLYTIC THROMBECTOMY SET EMBOLECTOMY CATHETER DXE POSSIS MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization