BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2895589 · Received January 3, 2013

    Report

    Report Number
    1058196-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Removal / Correction Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WITH THE REVIEW OF ADDITIONAL INFORMATION THE POTENTIAL FOR INJURY ASSOCIATED WITH THE REPORTED EVENT IS REMOTE; THEREFORE, THIS DOES NOT MEET THE REQUIREMENTS FOR A REPORTABLE EVENT. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN ADVANCED PROWLER SELECT LP ES PRESIDIO 18 8MMX30CM COIL, HE FELT GREAT FRICTION. SO HE CHANGED TO USE BOSTON EXCELSIOR SL-10 MICROCATHETER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15609259

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PRESIDIO COIL