BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER PLUS CATHETER

    MDR report key: 1922615 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02204
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K081804
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE DEVICE WAS RETURNED, AND ITS EVAL HAS BEEN COMPLETED. THE NEEDLE WAS EXTENDING OUT AND WAS OUT OF PLANE WITH THE HOUSING. THE NEEDLE FREELY ROTATED. DURING THE EVAL, THE NEEDLE ADVANCEMENT RING WAS ADVANCED BUT THE NEEDLE WAS NOT MOVING AT ALL. WHEN ATTEMPTED TO REMOVE THE LUER, IT CAME OFF EASILY AND APPEARED DETACHED FROM THE HYPO-TUBE. THERE WAS TRACE OF GLUE EVIDENCE ON THE GLUE PORT. THE ADHESIVE BOND BETWEEN THE LUER AND THE HYPO-TUBE WAS BROKEN. THE NEEDLE WAS PULLED OUT AND THERE WAS NO TRACE OF GLUE EVIDENT ON THE HYPO-TUBE. THE BOND BETWEEN THE LUER AND THE HYPO-TUBE WAS BROKEN. INSUFFICIENT APPLICATION OF GLUE IS THE LIKELY FACTOR.

    Description of Event or Problem · 1

    A PIONEER PLUS CATHETER WAS SELECTED FOR USE IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN SFA LESION. IT WAS REPORTED THAT DURING THE INITIAL PREPPING, THE USER EXTENDED THE NEEDLE TO THE 5TH NEEDLE DEPTH. UPON RETRACTION, THE NEEDLE DID NOT RETRACT. THE USER THEN ATTEMPTED TO SLIGHTLY EXTEND THE NEEDLE AND THEN RETRACT IT; HOWEVER, THE NEEDLE WOULD NOT RETRACT. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE CASE. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIONEER PLUS CATHETER DQY MEDTRONIC CARDIOVASCULAR NA 675817

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK