It was reported that treatment was being performed for a large avm.After the microcatheter (headway-duo) was positioned in the posterior circulation, the microcatheter lost position.During the attempt to withdraw the microcatheter back, the microcatheter detached completely inside the guide catheter.A balloon catheter was used to hold the detached segment to the guide catheter to remove it from the patient.There was no reported patient injury.
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Visual investigation of the returned device found that the device was separated 38cm from the proximal end.Close up images of both the proximal and distal sides of the separation were taken along with magnification x1500 photos of the broken coil and braid.For comparison, other duo samples were obtained and were separated in the following ways: tensile pulled, cut with wire cutter, cut with scissors, cut with razor blade.Images were taken of these samples were compared to images of the returned device in an effort to determine how the unit failed.It was able to be determined that the unit did not experience a tensile failure.It appears that the sample was cut.The investigation of the returned headway found it to be severed 38cm from the proximal end.The break appears to be the result of shear/cutting force rather than tensile force based on profile of the break and comparative testing.The physical evaluation of the device could not identify the conditions or circumstances that led to this cut, but the cut would have had to occur while the headway duo was out of the guide catheter.
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