BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR SL-10 150CM 2 TIP

    MDR report key: 6074186 · Received November 2, 2016

    Report

    Report Number
    3008853977-2016-00199
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 8, 2015
    Report Date
    January 25, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    PMA / PMN Number
    K013789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. VESSEL PERFORATION AND HEMORRHAGE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU); THEREFORE, ANTICIPATED IN NATURE. HOWEVER, BECAUSE THE DEVICE WAS NOT RETURNED THE EXACT CAUSE FOR THE DIFFICULTIES ENCOUNTERED DURING REMOVAL OF THE DEVICE CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING PROCEDURE, THE MICROCATHETER (SUBJECT DEVICE) AND A GUIDEWIRE WERE CROSSED THROUGH THE REMAINING THROMBUS. IT WAS REPORTED THAT AFTER CROSSING THE TARGET LESION, ANGIOGRAPHY REVEALED A SUBARACHNOID HEMORRHAGE (SAH) DUE TO A PERFORATION. THE SAH WAS NOT SERIOUS; THEREFORE, ADDITIONAL TREATMENT WAS NOT ADMINISTERED. THE PHYSICIAN STATED THAT SAH "WAS CAUSED BY PERFORATION WITH EITHER THE MICROCATHETER OR GUIDEWIRE." THE PATIENT WAS REPORTED TO HAVE RECOVERED AND IS IN STABLE CONDITION.

    Description of Event or Problem · 1

    DURING PROCEDURE, THE MICROCATHETER (SUBJECT DEVICE) AND A GUIDEWIRE WERE CROSSED THROUGH THE REMAINING THROMBUS. IT WAS REPORTED THAT AFTER CROSSING THE TARGET LESION, ANGIOGRAPHY REVEALED A SUBARACHNOID HEMORRHAGE (SAH) DUE TO A PERFORATION. THE SAH WAS NOT SERIOUS; THEREFORE, ADDITIONAL TREATMENT WAS NOT ADMINISTERED. THE PHYSICIAN STATED THAT SAH "WAS CAUSED BY PERFORATION WITH EITHER THE MICROCATHETER OR GUIDEWIRE.¿ THE PATIENT WAS REPORTED TO HAVE RECOVERED AND IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722838 EXCELSIOR SL-10 150CM 2 TIP CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other GUIDEWIRE (0.014IN ASAHI INTECC)