BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINNAKER

    MDR report key: 1972019 · Received January 27, 2011

    Report

    Report Number
    2939204-2011-00024
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K965189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SHAFT BREAK. IT SHOULD BE NOTED THAT THE PHYSICIAN WAS AWARE OF THE DIRECTION FOR USE (DFU) WARNING INDICATING THAT THE SPINNAKER ELITE FLOW DIRECTED MICROCATHETER IS NOT INTENDED OR INDICATED FOR USE WITH GLUE OR GLUE MIXTURES.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE DEVICE WAS RETAINED; THEREFORE, ANALYSIS CANNOT BE PERFORMED. BASED ON REVIEW OF THE INFORMATION AVAILABLE, THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DIRECTION FOR USE (DFU). THE DFU INDICATES "DO NOT USE SPINNAKER FLOW DIRECTED MICROCATHETER WITH GLUE OR GLUE MIXTURES. USE OF GLUE OR GLUE MIXTURES CAN CAUSE MICROCATHETER RUPTURE RESULTING IN GLUE MIGRATION, WHICH MAY CAUSE SERIOUS INJURY, SUCH AS STROKE, OR EVEN DEATH, TO THE PATIENT." THEREFORE, A ROOT CAUSE OF USE/USER ERROR WILL BE ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING USED WITH HISTOACRYL TO EMBOLIZE AN ANTERIOVENOUS MALFORMATION (AVM) LOCATED IN THE CAROTID ARTERY WHEN IT BURST. THE HISTOACRYL IMMEDIATELY OCCLUDED THE RIGHT ICA AND COLLATERAL VESSELS, THE RIGHT HEMISPHERE WAS BEING SUPPLIED BY COLLATERAL FLOW FROM THE LEFT HEMISPHERE. THE PATIENT WAS TRANSFERRED TO A PEDIATRIC CLINIC AND IS REPORTED TO REQUIRE FURTHER NEUROLOGICAL TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING USED WITH HISTOACRYL TO EMBOLIZE AN ANTERIOVENOUS MALFORMATION (AVM) LOCATED IN THE CAROTID ARTERY WHEN IT BURST. THE HISTOACRYL IMMEDIATELY OCCLUDED THE RIGHT ICA AND COLLATERAL VESSELS, THE RIGHT HEMISPHERE WAS BEING SUPPLIED BY COLLATERAL FLOW FROM THE LEFT HEMISPHERE. THE PATIENT WAS TRANSFERRED TO A PEDIATRIC CLINIC AND IS REPORTED TO REQUIRE FURTHER NEUROLOGICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINNAKER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M00355902020 0012981823

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R HISTOACRYL GLUE (UNKNOWN MANUFACTURER)