BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHER GUIDEWIRE

    MDR report key: 2973077 · Received February 21, 2013

    Report

    Report Number
    2953200-2013-00313
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K101339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 ACCESSORY PRODUCTS IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT AFTER REMOVING THE GUIDEWIRE FROM THE PATIENT A NURSE NOTICED WHILE DURING ROLLING IT UP THAT THE PTFE COATING SEPARATED FROM THE STEEL CORE OF THE WIRE. THIS WAS NOTED WITH ONE OF TWO WIRES THAT WERE USED IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE WIRE WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED. WHILE THE WIRE WAS STILL WITHIN THE SEALED POUCHES, COATING COULD BE SEEN FLAKING OFF OF THE WIRE. THERE WERE ALSO FLAKES OF COATING OBSERVED WITHIN THE BAG. THE DISTANCE FROM THE PROXIMAL WELD TO THE FIRST SECTION OF MISSING/PARTIAL COATING WAS 25 MM. THE DISTANCE FROM THE COATING START AT PROXIMAL END OF THE WIRE TO THE FIRST SECTION OF PARTIAL/MISSING COATING WAS 54 MM. THE LONGEST UNCOATED REGION WAS 46 MM (SMALL PIECES OF COATING WERE STILL PRESENT, BUT NOT SIGNIFICANT). AROUND 20 MEDIUM-LARGE UNCOATED/PARTIALLY COATED REGIONS WERE OBSERVED OVER THE ENTIRE LENGTH OF WIRE. THE MAJORITY OF COATING WAS MISSING IN THE DISTAL HALF OF THE WIRE, CLOSER TO THE PROXIMAL WELD. A TAPE TEST WAS CONDUCTED AND THE WIRE FAILED THE TEST SINCE COATING WAS TRANSFERRED FROM THE WIRE TO THE TAPE. THE TAPE TEST WAS ALSO CONDUCTED DISTAL TO THE PROXIMAL WELD AND PASSED; NO COATING WAS TRANSFERRED TO THE TAPE. COATING WAS FOUND TO BE MISSING OR FLAKING OFF FROM MULTIPLE SEGMENTS OF THE WIRE. THE CAUSE OF THE COATING FLAKING OFF IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75954 ARCHER GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC CARDIOVASCULAR GFVK0803

    Patients

    Seq Age Sex Outcome Treatment
    1