BEUDAMED
    FDA Adverse Event Death Summary report: N

    JETSTREAM G3

    MDR report key: 1654351 · Received April 7, 2010

    Report

    Report Number
    3003603429-2010-00012
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    March 10, 2010
    Report Date
    April 7, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE, NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION.

    Description of Event or Problem · 1

    THE JETSTREAM G3 DEVICE WAS USED FOR THROMBECTOMY OF A 15CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS ADVANCED TO THE LESION IN THE PROXIMAL SFA USING MINIMUM DIAMETER MODE THROUGH THE PROXIMAL 6CM OF LESION WITH NORMAL RESISTANCE. FURTHER ADVANCEMENT WAS MADE UNTIL SIGNIFICANT RESISTANCE WAS FELT BY THE PHYSICIAN. CONSIDERING THE LESION TYPE (HEAVY CLOT/THROMBUS), THE DECISION WAS MADE TO REMOVE THE DEVICE FROM THE PATIENT AND FLUSH THE CATHETER. UPON RE-ENTRY, THE CATHETER WAS RE-ADVANCED TO THE LESION AND PROCEEDED WITH MINIMUM DIAMETER MODE. THE DEVICE AGAIN MET SIGNIFICANT RESISTANCE IN A PORTION OF THE LESION. THE DECISION WAS MADE TO REMOVE THE DEVICE AND DISCONTINUE FURTHER USE. AFTER REMOVAL OF THE DEVICE, THE PATIENT CODED AND ULTIMATELY EXPIRED WHILE STILL IN THE PROCEDURE. PATIENT HAD BECOME NON-RESPONSIVE EARLIER IN THE CASE BEFORE THE INTRODUCTION OF THE JETSTREAM G3 DEVICE. THE PATIENT STABILIZED BUT HAD BLOOD PRESSURE ISSUES. THROUGHOUT TREATMENT OF THE LESION, THE PATIENT'S BLOOD PRESSURE DROPPED. PATIENT HAD SIGNIFICANT COMORBIDITIES INCLUDING STROKE, PRIOR THROMBECTOMY (3 WEEKS PRIOR) AND EMBOLECTOMY (1 WEEK PRIOR). PATIENT HAD AN INFUSION CATHETER PLACED THE DAY BEFORE AND RECEIVED A TPA DRIP OVERNIGHT. SHE WAS CONSIDERED HIGH RISK FOR FURTHER INTERVENTION. THE PHYSICIAN AND STAFF SPECULATED THAT SHE MAY HAVE SUFFERED ANOTHER STROKE DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100210

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death