BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 SOFT 5MM X 20CM

    MDR report key: 3781554 · Received April 30, 2014

    Report

    Report Number
    3008853977-2014-00139
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT MAIN COIL HAD BEEN DETACHED FROM THE DELIVERY WIRE AND APPEARS TO HAVE DETACHED VIA ELECTROLYSIS. THE DELIVERY WIRE WAS KINKED AT 10 CM, 38 CM, AND 55 CM FROM THE PROXIMAL END. THE OBSERVED DAMAGE TO THE COIL DELIVERY WIRE IS LIKELY DUE TO THE HANDLING OF THE DEVICE DURING USE. THE LONG DETACHMENT IS LIKELY DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. ANALYSIS OF THE DEVICE AND THE INFORMATION AVAILABLE DID NOT SHOW THAT THE COIL PREMATURELY DETACHED. 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 PROCEDURE, TWO DETACHMENT CYCLE ATTEMPTS WERE MADE TO DETACH THE COIL. AFTER BOTH DETACHMENT ATTEMPTS, THE DELIVERY WIRE WAS RETRIEVED AND IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE COIL WAS NOT DETACHED. THE COIL WAS ADVANCED INTO THE ANEURYSM A THIRD TIME AND ANOTHER DETACHMENT ATTEMPT WAS MADE. WHEN THE DELIVERY WIRE WAS RETRIEVED, THE COIL WAS NOTED TO BE DETACHED IN THE MICROCATHETER. THE PROXIMAL END OF THE COIL WAS WAS PUSHED WITH A GUIDEWIRE INTO THE ANEURYSM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    DURING PROCEDURE, TWO DETACHMENT CYCLE ATTEMPTS WERE MADE TO DETACH THE COIL. AFTER BOTH DETACHMENT ATTEMPTS, THE DELIVERY WIRE WAS RETRIEVED AND IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE COIL WAS NOT DETACHED. THE COIL WAS ADVANCED INTO THE ANEURYSM A THIRD TIME AND ANOTHER DETACHMENT ATTEMPT WAS MADE. WHEN THE DELIVERY WIRE WAS RETRIEVED, THE COIL WAS NOTED TO BE DETACHED IN THE MICROCATHETER. THE PROXIMAL END OF THE COIL WAS PUSHED WITH A GUIDEWIRE INTO THE ANEURYSM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259687 TARGET 360 SOFT 5MM X 20CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 17305744

    Patients

    Seq Age Sex Outcome Treatment
    1