BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER PLUS CATHETER

    MDR report key: 1922668 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02206
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K081804
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED, AND ITS EVALUATION HAS BEEN COMPLETED. THE NEEDLE WAS EXTENDING OUT AND WAS OUT OF PLANE WITH THE HOUSING. DURING EVALUATION, THE NEEDLE ADVANCEMENT RING WAS ADVANCED BUT THE NEEDLE WAS NOT MOVING AT ALL. WHEN ATTEMPTING TO REMOVE, THE CLIP AT THE LUER CAME OUT WITHOUT ANY RESISTANCE. THE LUER WAS FOUND DETACHED FROM THE HYPO-TUBE. THE ADHESIVE BOND BETWEEN THE LUER AND THE HYPO-TUBE APPEARED BROKEN. THE NEEDLE WAS PULLED OUT THROUGH THE DISTAL END. NO KINKS ON THE NEEDLE OR SHAFT. THERE WAS MINIMAL AMOUNT OF GLUE ON THE GLUE PORT. VERY LITTLE GLUE, CLOSE TO NONE, WAS ON THE HYPO-TUBE. THE MICRO BLAST ON THE HYPO-TUBE SURFACE DOES NOT LOOK ROUGH ENOUGH, WHICH COULD CAUSE THE GLUE NOT TO ADHERE PROPERLY. THE BOND BETWEEN THE LUER AND HYPO-TUBE WAS BROKEN DUE TO INSUFFICIENT APPLICATION OF GLUE.

    Description of Event or Problem · 1

    A PIONEER PLUS CATHETER WAS SELECTED FOR USE IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN UNK LESION. IT WAS REPORTED THAT WHEN PREPPING THE CATHETER, THE NEEDLE WOULD NOT RETRACT. A SECOND PIONEER PLUS CATHETER WAS USED TO COMPLETED THE CASE SUCCESSFULLY. 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 662923

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK