Results: the smart coil pusher assembly was kinked approximately 11.0, 12.0, 28.0, and 65.0 cm from the proximal end.The smart coil was fractured approximately 66.0 cm from the proximal end.Conclusions: evaluation of the device revealed a fractured pusher assembly.This damage was likely a result of forceful handling during use.If the pusher assembly is forcefully manipulating at extreme angles it may become kinked.Further forceful manipulation of the pusher assembly may cause it to become fractured.Further evaluation revealed multiple kinks along the pusher assembly¿s length.This damage was likely incidental and reportedly occurred during packaging for return to penumbra facilities.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, after successfully deploying and detaching multiple smart coils in the target vessel using a non-penumbra microcatheter, the physician accidentally kinked a smart coil pusher assembly while attempting to advance it into the microcatheter.Therefore, the smart coil was removed and while unintentionally detached as the technician was winding the it outside the patient.The procedure was then completed using the same non-penumbra microcatheter and additional smart coils.There was no report of an adverse effect to the patient.
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