BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1833665 · Received September 10, 2010

    Report

    Report Number
    3003603429-2010-00035
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 10, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. THE GUIDEWIRE WAS RETURNED IN THE DEVICE. THE DETACHED TIP OF THE GUIDEWIRE WAS NOT RETURNED AND IT COULD NOT BE DETERMINED WHETHER THE JETSTREAM G3 DEVICE CAUSED THE GUIDEWIRE BREAK. IT IS UNKNOWN WHETHER THE GUIDEWIRE BREAK WAS DUE TO INTERACTION WITH THE JETSTREAM G3 DEVICE.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 2.5 CM LESION LOCATED IN THE DISTAL COMMON FEMORAL ARTERY (CFA) AND OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE MADE 2 PASSES IN MINIMUM DIAMETER MODE AND 2 PASSES IN MAXIMUM DIAMETER MODE. THE DEVICE WAS RETRACTED BACK IN NORMAL OPERATION, UNTIL IT WAS OUTSIDE OF THE PATIENT. ANGIOGRAPHY WAS PERFORMED AND SHOWED A TERRIFIC RESULT. THE PHYSICIAN WANTED TO RE-INSERT THE JETSTREAM G3 IN ORDER TO TREAT DISEASE IN THE DISTAL SFA. UPON RE-INSERTION, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE TIP OF THE DEVICE WAS NOT IN LINE WITH THE GUIDEWIRE IN THE BODY. THE DEVICE ALONG WITH THE GUIDEWIRE WERE REMOVED. UPON REMOVAL, IT WAS NOTICED THAT APPROXIMATELY 35 CMS OF THE DISTAL PORTION OF THE GUIDEWIRE REMAINED IN THE PATIENT. NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE GUIDEWIRE. THE PHYSICIAN DECIDED TO STOP AND PURSUE RETRIEVING THE GUIDEWIRE ON ANOTHER DAY. THE GUIDEWIRE EVENTUALLY MIGRATED DOWN AND A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2010 TO RETRIEVE THE REMAINING GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100519

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention