BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 2873890 · Received December 14, 2012

    Report

    Report Number
    3008853977-2012-00012
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    STRYKER NEUROVASCULAR-IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K113778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UPN AND LOT NUMBER OF THE DEVICE IS NOT KNOWN, HOWEVER THE USER FACILITY REPORTED THAT THE DEVICE SUBJECT OF THIS COMPLAINT WAS AN EXCELSIOR XT-27 MICROCATHETER. (B)(4): DEVICE NOT RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. PATIENT ANEURYSM BURST IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM THE MIDDLE CEREBRAL ARTERY (MCA), THE ANEURYSM RUPTURED AS THE GUIDEWIRE AND MICROCATHETER PASSED THROUGH. THE PHYSICIAN DID NOT RELATE THE EVENT TO THE DEVICE BUT RATHER TO THE DISEASE STATE OF THE PATIENT.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM THE MIDDLE CEREBRAL ARTERY (MCA), THE ANEURYSM RUPTURED AS THE GUIDEWIRE AND MICROCATHETER PASSED THROUGH. THE PHYSICIAN DID NOT RELATE THE EVENT TO THE DEVICE BUT RATHER TO THE DISEASE STATE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN_NEUROVASCULAR_PRODUCT MICROCATHETER DQY STRYKER NEUROVASCULAR-IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1