BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRE-SHAPED PROWLER MICROCATHETERS

    MDR report key: 1003281 · Received December 18, 2007

    Report

    Report Number
    1058196-2007-00186
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Date of Event
    November 21, 2007
    Report Date
    November 21, 2007
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K003925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    LEAKAGE WAS NOTED FROM THE HUB AND EXTENSION TUBE. DURING A TAE PROCEDURE OF THE RIGHT HEPATIC ARTERY, THE PROWLER MICROCATHETER WAS CONNECTED TO THE EXTENSION TUBE, THEN TO THE POWER INJECTOR WHEN THE LEAKAGE WAS NOTED. THE PHYSICIAN HELD THE CONNECTION PART WITH HIS HANDS, AND PROCEDURE WAS CONTINUED. THERE WAS NO ADVERSE EVENT. NO CRACK WAS FOUND ON THE HUB. NO INFORMATION WAS AVAILABLE IF THE HUB WAS NOTED TO BE ROUND OR OVAL. THE HUB OF THE CATHETER WAS CONNECTED TO THE FLUSH SYSTEM WITHOUT DIFFICULTY OR LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRE-SHAPED PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13132509

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR SHEATH INTRODUCER: TERUMO 4F