BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDT INTERNAL CAROTID SHUNT

    MDR report key: 905274 · Received October 29, 2004

    Report

    Report Number
    2648988-2004-00049
    Event Type
    Malfunction
    Date Received
    October 29, 2004
    Report Date
    October 29, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    SUNDT SHUNT NL850-5065 WAS USED DURING A CAROTID ENDARTERECTOMY. THE DOCTOR CLAMPED THE CAROTID AND ATTEMPTED TO ATTACH THE SHUNT FROM LOT 1040685 ONTO THE CAROTID ARTERY. SURGEON REPORTED OBSERVING A LOT OF BLEEDING. ALTHOUGH THIS PRODUCT IS LABELED AS A 3MMX4MM SHUNT, THE SURGEON THOUGH THE DEVICE LOOKED LARGER THAN HE IS USED TO USING. THE DEVICE WAS REMOVED AND A DIFFERENT NL850-5065 FROM LOT 1041102 WAS OPENED. THIS DEVICE LOOKED LIKE THE SIZE THE SURGEON IS USED TO, THE SHUNT WAS APPLIED, THE SURGERY PROCEEDED WITH NO FURTHER ISSUES. NO PATIENT INJURY WAS REPORTED AND THE DELAY WAS ONLY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNDT INTERNAL CAROTID SHUNT CAROTID/CARDIOVASCULAR DEVICE DWF INTEGRA NEUROSCIENCES, INC. * 1040685

    Patients

    Seq Age Sex Outcome Treatment
    1 *