BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XL 360 SOFT 10MM X 40CM

    MDR report key: 6051948 · Received October 24, 2016

    Report

    Report Number
    3008881809-2016-00230
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    07613327004601
    PMA / PMN Number
    K123377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT COMPLAINT COIL WAS RETURNED TOGETHER WITH THE MICROCATHETER USED DURING PROCEDURE. DEVICE ANALYSIS REVEALED THAT THE DELIVERY WIRE WAS KINKED, THE MAIN COIL WAS SEVERELY STRETCHED, THE INTERNAL SUTURE WAS BROKEN AND IT WAS BROKEN IN TWO PIECES. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD NOTED IN THE INTRODUCER SHEATH, THE SUBJECT DEVICE AND IN THE MICROCATHETER WHICH IS INDICATIVE OF INADEQUATE FLUSH. BASED ON ADDITIONAL INFORMATION RECEIVED THE DEVICE WAS IN GOOD CONDITION PRIOR TO USE, AND INTERMITTENT FLUSH WAS USED WHICH IS CONSISTENT WITH BLOOD FOUND. AS PER THE DFU, "CAUTION: IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF STRYKER NEUROVASCULAR MICROCATHETERS AND TO MAINTAIN THE LUBRICITY OF THE HYDROLENE® COATING SURFACE, IT IS CRITICAL THAT A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE STRYKER NEUROVASCULAR MICROCATHETER AND GUIDE CATHETER, AND THE MICROCATHETER AND ANY INTRALUMINAL DEVICE. IN ADDITION, FLUSHING AIDS IN PREVENTING CONTRAST CRYSTAL FORMATION AND/OR CLOTTING ON BOTH THE INTRALUMINAL DEVICE AND INSIDE THE GUIDE CATHETER AND/OR THE MICROCATHETER LUMEN". IT IS LIKELY THAT INSUFFICIENT FLUSH CONTRIBUTED TO THE OBSERVED MAIN COIL BREAK AND ADDITIONAL DAMAGES. BASED ON ANALYSIS RESULTS AND INFORMATION AVAILABLE AN ASSIGNABLE CAUSE OF USE ERROR WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE SUBJECT DEVICE INSPECTION REVEALED THAT THE MAIN COIL WAS FRACTURED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703097 TARGET XL 360 SOFT 10MM X 40CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 18542946 07613327004601

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXCELSIOR 1018 MICROCATHETER (STRYKER)