The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil into another manufacturer¿s microcatheter, the physician introduced the smart coil introducer sheath into the hub of the non-penumbra microcatheter; however, the introducer sheath did not completely seat firmly in the hub taper.Consequently, the smart coil came out of its introducer sheath and began forming right at the hub of the microcatheter.After multiple failed attempts to advance the smart coil into the microcatheter, the physician decided to remove the coil.It was noted that the physician was able to push the coil out of its introducer sheath on the back table.The procedure was then completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
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Results: the embolization coil was intact with the pusher assembly.The embolization coil had gaps and offset coil winds near its proximal end.Conclusions: evaluation of the returned device revealed that the embolization coil had gaps and offset coil winds near its proximal end.This damage likely occurred due to forcefully advancing the smart coil when the introducer sheath was not properly seated in the hub.During functional analysis, the gaps and offset coil winds caused resistance when advancing the smart coil through its introducer sheath and a demonstration microcatheter.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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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