BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUGAR XT 190CM STRT TIP

    MDR report key: 2063244 · Received April 6, 2011

    Report

    Report Number
    1220452-2011-00019
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 1, 2009
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    PMA / PMN Number
    K032899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.

    Description of Event or Problem · 1

    FIELD ASSURANCE DEPARTMENT AT THE (B)(4) SITE WAS MADE AWARE VIA MEDWATCH SENT FROM FDA. ARRIVED IN (B)(4) ON (B)(4), 2011. THE USER REPORT NUMBER IS (B)(4). THE FIELD ASSURANCE DEPARTMENT CONTACTED THE ACCOUNT TO OBTAIN ADD'L INFO AND THE PRODUCT SAMPLE WILL BE RETURNING FOR EVAL. THE FACILITY ADVISED THAT AN ERROR WAS MADE AND THE MFR, FIELD ASSURANCE DEPT, OR THE SALES REP WERE NEVER NOTIFIED OF THE EVENT. IT HAS BEEN REPORTED TO US THAT THE GUIDE WIRE BECAME FRAYED DURING THE PROCEDURE. THE GUIDE WIRE WAS INSERTED AND RE-INSERTED INTO THE PT'S ARTERY SEVERAL TIMES AND BECAME FRAYED. WE DID NOT RECEIVE A RESPONSE FROM THE MFR REGARDING THE COUGAR XT GUIDE WIRE. THE ORIGINAL INTENDED PROCEDURE WAS ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUGAR XT 190CM STRT TIP DQX MEDTRONIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA