BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2110791 · Received June 1, 2011

    Report

    Report Number
    1058196-2011-00271
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    May 9, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT BASED ON ADDITIONAL INFORMATION, THE EVENT DOES NOT MEET REPORTING CRETIRIA. THEREFORE, NO FURTHER INFORMATION WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00270 AND 1058196-2011-00271.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00270 AND 1058196-2011-00271. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE VRD, THE ENTERPRISE (ENC451412) WOULD NOT GO INTO THE PROWLER PLUS MICROCATHETER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15081036

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE SYSTEM