BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 1585771 · Received January 18, 2010

    Report

    Report Number
    1058196-2010-00020
    Event Type
    Malfunction
    Date Received
    January 18, 2010
    Date of Event
    December 24, 2009
    Report Date
    December 25, 2009
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K993266
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS BELOW THE KNEE (CTO). THE VESSEL WAS NOT CALCIFIED OR TORTUOUS. RATE OF STENOSIS WAS UNK. THE PROWLER MICROCATHETER 606-2511 (COMPLAINT PRODUCT) BECAME STUCK AT THE TARGET LESION DURING ADVANCEMENT. AS THE CATHETER WAS PULLED BACK WITH STRONG FORCE, IT APPEARED TO BE STRETCHED. THE CATHETER WAS PULLED BACK ENTIRELY FROM THE PT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT WITHOUT PT INJURY. THE DEVICE DID NOT KINK OR BEND AT ANYTIME PRIOR TO THE RESISTANCE/FRICTION. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK OR BEND AT ANY TIME. THE DEVICE HAD NOT BEEN RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13470697

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR CRUISE GUIDEWIRE