BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUGAR GUIDE WIRE - CRDM

    MDR report key: 2952624 · Received February 9, 2013

    Report

    Report Number
    1220452-2013-00011
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY #ACCESSORY LOT GG731: THE GUIDEWIRE WAS RETURNED AND ANALYZED. THE LEAD ACCESSORIES STYLET/GUIDEWIRE WAS KINKED/BUCKLED. THE LEAD ACCESSORIES STYLET/GUIDEWIRE HAD BLOOD. VISUAL ANALYSIS NOTED THERE WAS DAMAGED AT IMPLANT. THE GUIDEWIRE IS BENT AT VARIOUS LOCATIONS, BLOOD/TISSUE (CODED LE01IBOW) VISIBLE THROUGHOUT. SOME FORCE WAS USED TO DAMAGE THE GUIDEWIRE AT VARIOUS LOCATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE WAS SUSPECTED OF A MATERIAL INTEGRITY DEFECT AT THE PROXIMAL END WHICH CAUSED DAMAGE TO TWO ATTEMPTED LEADS. THE GUIDEWIRE WAS REPLACED FOR THE THIRD LEAD IMPLANT ATTEMPT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55638 COUGAR GUIDE WIRE - CRDM WIRE, GUIDE, CATHETER DQX MEDTORNIC, INC LVCXT190S GG731

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR