BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX2 360 DEGREES SOFT SR COIL

    MDR report key: 1021022 · Received March 27, 2008

    Report

    Report Number
    2939204-2008-00101
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DIRECTIONS FOR USE (DFU) WARNS : " DUE TO THE DELICATE NATURE OF THE MATRIX2 DETACHABLE COILS, THE TORTUOUS VASCULAR PATHWAYS THAT LEAD TO CERTAIN ANEURYSMS AND VESSELS, AND THE VARYING MORPHOLOGIES OF INTRACRANIAL ANEURYSMS, A COIL MAY OCCASIONALLY STRETCH WHILE BEING MANEUVERED. STRETCHING IS A PRECURSOR TO POTENTIAL MALFUNCTIONS.." AS WELL, PER THE DFU: " IF MATRIX2 DETACHABLE COIL REPOSITIONING IS NECESSARY, TAKE SPECIAL CARE TO RETRACT THE COIL UNDER FLUOROSCOPY IN A ONE-TO-ONE MOTION WITH THE DELIVERY WIRE. IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL."

    Description of Event or Problem · 1

    A COILING PROCEDURE OF AN INTRACRANIAL ANEURYSM WAS REPORTED TO THE MFR ON FEB 28, 2008. THE PT CONDITION PRIOR TO THE PROCEDURE WAS HUNT AND HESS GRADE 4. WHILE THE PHYSICIAN WAS DEPLOYING A COIL (SUBJECT DEVICE) INTO AN ANEURYSM, THE PHYSICIAN " ... SAW THAT THE COIL BECAME TANGLED WITH ANOTHER COIL THAT WAS ALREADY IN THE ANEURYSM." THE PHYSICIAN TRIED TO PULL THE SUBJECT DEVICE BACK, AND REALIZED THAT IT HAD STRETCHED. THE SUBJECT DEVICE WAS REMOVED, AND THE PHYSICIAN SUCCESSFULLY DEPLOYED A STENT TO ADHERE THE COILS BACK INTO THE ANEURYSM BECAUSE A COUPLE OF LOOPS OF THE PREVIOUS COILS WERE DIPPING OUT OF THE ANEURYSM. THE PT CONDITION FOLLOWING THE PROCEDURE " .. WAS STILL GRADE 4 SIMILAR TO PRIOR TREATMENT; HOWEVER, THE ANEURYSM WAS SECURE WITH COILS AND STENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 360 DEGREES SOFT SR COIL HCG DEVICE, NEUROVASCULAR EMBOLIZATION HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 490306-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL10 MICROCATHETER| TWO MATRIX2 COILS