Medtronic received a report that a pipeline experienced resistance in a phenom 27 microcatheter and the proximal part of the pushwire broke.
A non-medtronic guidewire also experienced resistance.
The patient was undergoing treatment for a basilar fusiform aneurysm.
The patient's vessel tortuosity was severe.
The access vessel was the femoral artery, which was 4mm in diameter.
It was reported that a merit flexor short touhy was used in this case, and the pipeline got stuck in the touhy.
They tried to pull the pipeline out, and got the implant out of touhy/phenom 27 catheter hub.
Then, a synchro guidewire would not advance through the phenom 27.
The 15mm distal of the pipeline pusher wire tip and polyurethane flaps broke off in the phenom 27.
It was believed that this was caused by the touhy.
The catheter was removed.
They tried to advance a wire through the phenom but could not because the pipeline wire tip remained in the catheter.
The phenom was cut open and it was confirmed the wire was in the device.
A new phenom catheter was used, but they kept the same short touhy and were met with resistance in advancing the pipeline again.
They were able to save this pipeline and changed to a normal touhy, and all went fine thereafter.
the patient did not experience any injury or complications.
The devices were prepared and flushed according to the instructions for use (ifu).
Ancillary devices include a phenom plus guide catheter.
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