BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGARDAORTIC ARCH WOVEN VASCULAR PROSTHESIS

    MDR report key: 726151 · Received November 16, 2005

    Report

    Report Number
    1640201-2005-00027
    Event Type
    Malfunction
    Date Received
    November 16, 2005
    Date of Event
    October 14, 2005
    Report Date
    October 17, 2005
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS INSPECTED BY THE QA/QC MANAGER, WHO CONFIRMED THE PRESENCE OF A SMALL BROWN SPOT. THE BROWN SPOT IS ALMOSE CERTAINLY CARBON, AND IS THUS INERT. WE ARE, HOWEVER, HAVING THIS VERIFIED KBY AN OUTSIDE LABORATORY. THIS SMALL BROWN SPOT SHOULD HAVE NORMALLY BEEN REJECTED DURING VISUAL INSPECTION. THE ISSE HAS BEEN DISCUSSED WITH THE QC INSPECTORS DURING THE ROUTINE QUALITY MEETINGS.

    Description of Event or Problem · 1

    DURING ROUTINE INSPECTION PERFORMED BY OUR DISTRIBUTOR A FOREIGN MATERIAL WAS FOUND ON A VASCULAR GRAFT. THEREWAS NO PATIENT INJURY AS THE DEVICE NEVER REACHED THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARDAORTIC ARCH WOVEN VASCULAR PROSTHESIS COLLAGEN COATED WOVEN VASCULAR PROSTHESIS DSY INTERVASCULAR HEWAA2210080810/1 05J08

    Patients

    Seq Age Sex Outcome Treatment
    1 *