BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER PLUS CATHETER

    MDR report key: 1854112 · Received September 2, 2010

    Report

    Report Number
    2953200-2010-01676
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K081804
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE PIONEER CATHETER WAS RETURNED AND ITS EVAL HAS BEEN COMPLETED. THE NEEDLE WAS NOT COMPLETELY WITHIN THE HOUSING AND WAS EXTENDING OUT 10 MM. DURING EVAL, THE NEEDLE DEPLOYED FINE; HOWEVER, WHEN IT WAS RETRACTED, IT DID NOT FULLY RETRACT INTO THE NEEDLE HOUSING AND IT WAS PROTRUDING APPROXIMATELY 3 MM. THE LUER CLIP WAS REMOVED. THE HYPOTUBE WAS NOT FULLY FLUSH AGAINST THE END OF ITS RAIL ON THE LUER. THE HYPOTUBE WAS PULLED BACK WITH A PAIR OF PLIERS, SO AS NOT TO DISTURB THE HYPOTUBE/LUER BOND. THE HYPOTUBE WAS MANUALLY PUSHED FLUSHED AGAINST THE LUER, WHICH INDICATED BOND FAILURE. THE LUER WAS EXAMINED UNDER THE MICROSCOPE AND NO EVIDENCE OF GLUE WAS SEEN AT THE FRONT OF THE HYPOTUBE CHANNEL IN THE LUER. THE LUER GLUE PORT HAD MINIMAL EVIDENCE OF GLUE AT THE GLUE PORT. THE LUER WAS SKIVED TO EXAMINE THE AMOUNT OF APPLIED GLUE AND THERE WAS AN INSUFFICIENT AMOUNT OF GLUE FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC PIONEER CATHETER WAS INSERTED IN A PT FOR THE TREATMENT OF AN OCCLUDED LEFT SFA. VESSELS WERE MODERATELY CALCIFIED, BUT TORTUOSITY WAS UNREMARKABLE. THE PIONEER PLUS DEVICE WAS TESTED WITHOUT ISSUES ON THE TABLE. THE NEEDLE MAY HAVE BEEN TESTED 1-2 TIMES. THE DEVICE WAS INSERTED IN THE PT AND ADVANCED TO THE LESION WITHOUT ISSUES USING A 6 FR SHEATH UP AND OVER THE AORTIC BIFURCATION. THE DEVICE WAS ORIENTED PROPERLY, AND THE NEEDLE WAS DEPLOYED SEVERAL TIMES; HOWEVER, THE TARGET WAS MISSED. EACH TIME, THE DEVICE WAS REPOSITIONED, TORQUED, AND THE NEEDLE DEPLOYED. AFTER THE 4TH OR 5TH TIME, THE NEEDLE WOULD NOT RETRACT AFTER DEPLOYMENT AND THE NEEDLE WAS ALL THE WAY OUT. THE DEVICE WAS CAREFULLY REMOVED FROM THE PT THROUGH A SHEATH WITHOUT INJURY TO THE PT. THERE WAS NO OTHER PIONEER AVAILABLE, AND THE CASE WAS ABORTED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT WAS 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