BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2467096 · Received February 15, 2012

    Report

    Report Number
    3003603429-2012-00002
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K111229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND GUIDEWIRE WERE EVALUATED AND NO ISSUES OR MALFUNCTION WERE FOUND WITH THE DEVICE. THE GUIDEWIRE SPRING TIP WAS FOUND BROKEN FROM THE WELD SPOT AT THE DISTAL END OF THE WIRE. THE REPORTED ISSUE WAS CONFIRMED, HOWEVER THE ROOT CAUSE OF THE WIRE BREAKAGE COULD NOT BE DETERMINED. PATIENT WAS REPORTED TO HAVE A HYPERCOAGUABLE BLOOD DISORDER. THE IFU STATES THAT PATIENTS WITH A HISTORY OF COAGULOPATHY OR A HYPERCOAGUABLE BLOOD DISORDER ARE IN THE SPECIAL PATIENT POPULATION AND SAFETY HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    THE JETSTREAM G3SF 1.6 DEVICE WAS USED TO TREAT A FIBROTIC LESION IN THE PERONEAL. IT WAS REPORTED THAT THE DEVICE WAS TIGHT OVER THE GUIDEWIRE AND ULTIMATELY THE WIRE WAS SHEARED OFF. THE WIRE WAS RETRIEVED AND THE CASE CONTINUED SUCCESSFULLY WITH A NEW DEVICE AND GUIDEWIRE. THE PATIENT WAS TREATED WITH A BALLOON AND STENT. FOLLOWING TREATMENT THE PATIENT CONTINUED TO CLOT DUE TO A CLOTTING DISORDER AND WAS TAKEN TO SURGERY FOR FURTHER TREATMENT NOT RELATED TO THE GUIDEWIRE BREAKAGE. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. 031004-001 111123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention