BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED 90 150CM

    MDR report key: 3071401 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00109
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING VISUAL INSPECTION OF THE DEVICE IT WAS NOTED THERE WAS A KINK NOTED AT 112 CM FROM THE HUB AND AT 145.5 CM FROM THE HUB. A FUNCTIONAL TEST WAS PERFORMED AND NO RESISTANCE WAS MET WHEN A MANDREL WAS INTRODUCED THROUGH THE CATHETER HUB AND ADVANCED THROUGH THE DISTAL END. THE CATHETER WAS FLUSHED WITH WATER AND THE WATER PROCEEDED TO COME OUT OF THE DISTAL END AND NO HOLE WAS OBSERVED. A ROOT CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THIS COMPLAINT, AS IT WAS STATED THAT THE DEVICE WAS NOT USED THE LIKELY CAUSE OF THE DAMAGE NOTED COULD BE CAUSED DURING THE PREPARATION HANDLING OF THE DEVICE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE MICROCATHETER THE PHYSICIAN NOTED THERE WAS A HOLE BEHIND THE TIP OF THE CATHETER. THE PHYSICIAN HAD THE SAME ISSUE WITH A SECOND MICROCATHETER AND THE PROCEDURE WAS COMPLETED USING A THIRD MICROCATHETER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPRATION OF THE MICROCATHETER THE PHYSICIAN NOTED THERE WAS A HOLE BEHIND THE TIP OF THE CATHETER. THE PHYSICIAN HAD THE SAME ISSUE WITH A SECOND MICROCATHETER AND THE PROCEDURE WAS COMPLETED USING A THIRD MICROCATHETER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172393 EXCELSIOR SL-10 PRE-SHAPED 90 150CM CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK 15504558

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXCELSIOR MICROCATHETER (BOSTON SCIENTIFIC)