BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6360043 · Received February 27, 2017

    Report

    Report Number
    3002808486-2017-00667
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: AS NO PRODUCT, PHOTOS OR IMAGING RECEIVED TO SUPPORT THIS INVESTIGATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. ACCORDING TO THE COMPLAINT HISTORY, DEVICE OCCLUSION OCCURRED UNDER THE HUB-CANNULA GLUING PROCESS. THIS ISSUE MAY HAVE OCCURRED DURING THE MANUFACTURING PROCESSES. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: NOT POSSIBLE TO INTRODUCE THE WIRE INTO TO THE LUER LOCK VALVE. PATIENT ON THE TABLE - ALTERNATIVE PRODUCT NOT AVAILABLE. ONLY WAY OUT WAS TO DRILL THE VALVE OPEN - FOREIGN PLASTIC PIECE WAS DISCOVERED AND REMOVE. PROCEDURE COULD BE CONTINUED. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145676 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346731

    Patients

    Seq Age Sex Outcome Treatment
    1