BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHER GUIDEWIRE

    MDR report key: 2974260 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00316
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K101339
    Removal / Correction Number
    2182208-3-13-2013-003-R
    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

    THE WIRE EXAMINED WAS NOT FULLY SEATED WITHIN THE HOOP. WHILE THE WIRE WAS STILL WITHIN THE HOOP, COATING COULD BE SEEN SEPARATING FROM THE WIRE. THE DISTANCE FROM THE PROXIMAL WELD TO THE FIRST SECTION OF MISSING/PARTIAL COATING WAS 20 MM. THE DISTANCE FROM THE COATING START AT PROXIMAL END OF THE WIRE TO THE FIRST SECTION OF PARTIAL/MISSING COATING WAS LESS THAN 1 MM. THE LONGEST UNCOATED REGION WAS 170 MM (SMALL PIECES OF COATING WERE STILL PRESENT, BUT NOT SIGNIFICANT). ALMOST THE ENTIRE LENGTH OF THE WIRE HAS MISSING COATING.

    Description of Event or Problem · 1

    AN ARCHER GUIDEWIRE WAS USED AS AN ACCESSORY PRODUCT IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF A GREATER THAN 5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. A 7FR INTRODUCER SHEATH WAS USED. IT WAS REPORTED THAT THE GREEN OUTER COATING OF THE ARCHER WIRE CAME OFF DURING THE PROCEDURE. THE COATING COMING OFF WAS NOTICED WHEN THE DELIVERY SYSTEM WAS PULLED BACK AFTER THE STENT GRAFT WAS IMPLANTED. THE PHYSICIAN COULD SEE UNDER X-RAY THAT PARTS OF THE COATING REMAIN IN THE PATIENT. THE PATIENT IS FINE. THE WIRE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77678 ARCHER GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC CARDIOVASCULAR GFWA0387

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR