BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHER GUIDEWIRE

    MDR report key: 2974288 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00322
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K101339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: LACK OF INFORMATION (CAUSE OF EVENT IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE OF EVENT IS UNKNOWN).

    Description of Event or Problem · 1

    AN ARCHER GUIDEWIRE WAS USED AS AN ACCESSORY PRODUCT IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT THE GREEN COATING ALONG THE WIRE WAS COMING OFF. IT IS UNKNOWN IF ANY OF THE GREEN COATING REMAINED IN THE PATIENT. THIS WAS OBSERVED AFTER THE STENT GRAFT WAS IMPLANTED. SOME OF THE GREEN COATING WAS FOUND IN THE INTRODUCER SHEATH THAT WAS USED DURING THE PROCEDURE. THE PATIENT IS FINE. THE WIRE WAS RETURNED FULLY SEATED WITHIN THE STORAGE HOOP. WHILE THE WIRE WAS STILL WITHIN THE HOOP COATING COULD BE SEEN STICKING TO THE HOOP AND FLAKING OFF OF THE WIRE. ONCE THE WIRE WAS REMOVED FROM THE HOOP DISTINCT SEGMENTS OF COATED AND UNCOATED AREAS COULD BE SEEN; THE COATING WAS MISSING CIRCUMFERENTIALLY. IN SOME SECTIONS, THE COATED COULD BE MOVED BACKWARDS AND FORWARDS FREELY OVER THE WIRE; THE ID OF THE COATING WAS NO LONGER ADHERED TO THE OD OF THE WIRE. THE DISTANCE FROM THE PROXIMAL WELD TO THE FIRST CIRCUMFERENTIAL VOID WAS 28 MM. THE DISTANCE FROM THE COATING START AT PROXIMAL END OF THE WIRE TO THE FIRST CIRCUMFERENTIAL VOID WAS 35 MM. THE LONGEST CONTINUOUS UNCOATED REGION WAS 126 MM. THERE WERE APPROXIMATELY 15 LARGE UNCOATED REGIONS OVER THE ENTIRE LENGTH OF THE WIRE. ON THE PROXIMAL END, THE DISTANCE FROM FIRST VOID TO THE SECOND VOID WAS 20 MM. THE WIRE FAILED THE TEST SINCE COA TING WAS TRANSFERRED FROM THE WIRE TO THE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78693 ARCHER GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC CARDIOVASCULAR GFVL0334

    Patients

    Seq Age Sex Outcome Treatment
    1