BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE GOLD IVUS IMAGING CATHETER

    MDR report key: 2062501 · Received March 21, 2011

    Report

    Report Number
    2939520-2011-00009
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 23, 2011
    Manufacturer
    VOLCANO CORP
    Product Code
    OBJ
    PMA / PMN Number
    K073473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION WAS PERFORMED. IT WAS OBSERVED THAT THE ADHESIVE FILLET ON THE DISTAL END OF THE SCANNER WAS MISSING. IT WAS CONFIRMED THAT THE ADHESIVE FILLET WAS NOT APPLIED TO THE DEVICE. THIS IS DEEMED A MANUFACTURING DEFECT. THE PURPOSE OF THE ADHESIVE FILLET IS TO PROVIDE SMOOTH TRACTABILITY IN A TORTUOUS PATH. THE DEVICE WAS NEVER INSERTED IN THE PT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE FIRM WILL EVALUATE RESPECTIVE MANUFACTURING CONTROL PROCESSES AND DOCUMENTATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH PROPOSED CORRECTIVE AND/OR PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CONNECTED TO THE SYSTEM FOR A DIAGNOSTIC PROCEDURE BUT THE SYSTEM FAILED TO RECOGNIZE THE CATHETER. THE DEVICE WAS NOT INSERTED IN THE PT. A SECOND DEVICE WAS USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE GOLD IVUS IMAGING CATHETER INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORP 85900 002 16101

    Patients

    Seq Age Sex Outcome Treatment
    1