BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET SOLENT PROXI THROMBECTOMY SET

    MDR report key: 3259937 · Received July 30, 2013

    Report

    Report Number
    2183460-2013-00009
    Event Type
    Other
    Date Received
    July 30, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 23, 2013
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT PRESENTED FOR A RIGHT ARM VENOUS THROMBECTOMY. IT IS NOT KNOWN IF THE VESSEL WAS PARTIALLY OR HAD A TOTAL OCCLUSION. THE PHYSICIAN USED AN ANGIOJET SOLENT PROXI THROMBECTOMY SET TO PERFORM THROMBECTOMY. DURING THE PROCEDURE, THE PATIENT DEVELOPED CHEST TIGHTNESS AND TINGLING ACROSS THE CHEST DURING ANGIOJET THERAPY. THIS OCCURRED FOUR TIMES, 110, 139, 200 AND 247 SECOND MARK OF ANGIOJET THERAPY. AFTER THE FOURTH INCIDENT, THE PHYSICIAN DECIDED TO STOP USING THE ANGIOJET DEVICE AND DRIPPED PLASMINOGEN ACTIVATOR (TPA) OVERNIGHT WITH CRAGG MACNAMARA CATHETER (COVIDIEN). THE ANGIOJET SOLENT FAMILY INSTRUCTIONS FOR USE (IFU) WARNS THE USER: "CARDIAC ARRHYTHMIAS DURING CATHETER OPERATION HAS BEEN REPORTED IN A SMALL NUMBER OF PATIENTS. CARDIAC RHYTHM SHOULD BE MONITORED DURING CATHETER USE AND APPROPRIATE MANAGEMENT, SUCH AS TEMPORARY PACING, BE EMPLOYED, IF NEEDED." THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS THE ASSOCIATION BETWEEN THE ANGIOJET DEVICE AND NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT. IN ADDITION, THE PHYSICIAN'S DECISION TO STOP USING THE ANGIOJET DEVICE AND DRI TPA OVERNIGHT VIA A CATHETER COULD BE CONSIDERED AN INTERVENTION.

    Description of Event or Problem · 1

    PATIENT FOR RIGHT ARM VENOUS THROMBECTOMY, DEVELOPED CHEST TIGHTNESS AND TINGLING ACROSS CHEST WHEN ANGIOJET USED. THIS OCCURRED 4 TIMES AT 110, 137, 200 AND 247 SECONDS. STOPPED USING ANGIOJET AFTER 4TH TIME AND DRIPPED TPA OVERNIGHT WITH CRAFF MACNAMARA CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354553 ANGIOJET SOLENT PROXI THROMBECTOMY SET THROMBECTOMY SET DXE BAYER INTERVENTIONAL 109676-002 143716

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention