BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKSMAN MICROCATHETER

    MDR report key: 6958738 · Received October 18, 2017

    Report

    Report Number
    2029214-2017-01166
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 29, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    PMA / PMN Number
    K091559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER AND THE 5MAX ACE CATHETER WERE RETURNED FOR EVALUATION. THE MICROCATHETER WAS FOUND OUTSIDE OF THE 5MAX ACE CATHETER. THE CATHETERS WERE FOUND TO BE COMPATIBLE WITH EACH OTHER. THE RETURNED MICROCATHETER APPEARED TO BE SEPARATED INTO TWO SEGMENTS. A MINIMAL AMOUNT OF BLOOD WAS FOUND INSIDE THE CATHETER LUMEN. THE 5MAX ACE CATHETER BODY WAS FOUND TO BE KINKED AT SEVERAL LOCATIONS. THE 5MAX ACE WAS FLUSHED WITH WATER AND FOUND TO BE PATENT. THE 5MAX ACE COULD NOT BE USED FOR TESTING DUE TO ITS DAMAGED CONDITION. THE MICROCATHETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE MICROCATHETER TIP AND THE MARKER BAND WERE EXAMINED AND NO DAMAGES WERE FOUND. THE MICROCATHETER BODY WAS FOUND TO BE FLATTENED AND ACCORDIONED TOWARDS THE DISTAL TIP. THE MICROCATHETER BODY APPEARED TO BE SEPARATED AT 25.0 CM FROM THE DISTAL TIP. THE TUBING MATERIAL AT THE BROKEN ENDS EXHIBITED JAGGED EDGES, EXPOSED BRAID, STRETCHING AND NECKING. NO FLASH OR VOIDS MOLDED WERE OBSERVED IN THE HUB. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE MANDREL THROUGH MICROCATHETER TIP AND HUB. THE MANDREL WAS ABLE TO PASS THROUGH THE MICROCATHETER TIP AND HUB WITH SLIGHT RESISTANCE AND IT GOT STUCK AT THE DAMAGED LOCATIONS. NO OTHER ANOMALIES WERE OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MARKSMAN CATHETER IS EXPECTED TO RETURN FOR EVALUATION. ONCE RECEIVED AND EVALUATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT THE DEVICE RETURN, THE LIKELY CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING THE ACUTE STROKE / MECHANICAL THROMBOLYSIS PROCEDURE, THE MARKSMAN COULD NOT BE REMOVED. AFTER AN ATTEMPT WAS MADE TO REMOVE THE MICROCATHETER, THE DEVICE REPORTEDLY TORE AND WAS BROKEN ABOUT 25CM FROM THE DISTAL END. THERE WAS NO INJURY REPORTED. THE PATIENT WAS RECEIVING MECHANICAL THROMBECTOMY TREATMENT FOR A STROKE. THE DEVICES WERE PREPARED AS USUAL AND THE CATHETER WAS FLUSHED AS DIRECTED. THE MARKSMAN AND REPERFUSION CATHETER (NON-MEDTRONIC DEVICE) WERE NAVIGATED TO THE TOP OF THE INTERNAL CAROTID ARTERY TO REMOVE THE OCCLUSION. THE CLOT WAS PARTIALLY REMOVED BY SUCTIONING WITH THE MICROCATHETER AS PLANNED. IN ORDER TO REMOVE CLOT AT THE ANTERIOR CEREBRAL ARTERY (ACA), THE MARKSMAN AND GUIDEWIRE (NON-MEDTRONIC DEVICE) WERE DELIVERED TO THE DISTAL AC. HOWEVER, THERE WAS DIFFICULTY PASSING THE BIFURCATION FROM TOP OF THE INTERNAL CAROTID ARTERY THROUGH THE ACA DUE TO SEVERE TORTUOSITY AND THE MARKSMAN DID NOT ADVANCE SMOOTHLY. THE WIRE WAS ABLE TO BE DELIVERED TO THE A3 AND THE MARKSMAN TO THE A2. AN ATTEMPT WAS MADE TO DELIVER THE REPERFUSION CATHETER THROUGH THE MARKSMAN, BUT IT DID NOT PASS THE TORTUOUS VESSEL. THE DECISION WAS MADE TO REMOVE THE MARKSMAN FROM THE PATIENT, BUT IT BECAME STUCK. TWO ATTEMPTS WERE MADE TO REMOVE THE MARKSMAN BUT WERE UNSUCCESSFUL. IT WAS REPORTED THAT THE MARKSMAN TORE AFTER FORCIBLY PULLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737809 MARKSMAN MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR FA-55150-1030 A474796

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR