Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as offset coil winds may occur.Resistance was encountered as the smart coil embolization coil began to take shape inside the hub of the demonstration microcatheter and the smart coil could not be advanced any further.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually 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 in the basilar artery using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil to the target location and attempted to detach it without using a smart coil detachment handle; however, the smart coil was unable to detach, despite the physician repositioning the smart coil and attempting multiple times.The physician, therefore, attempted to remove the smart coil, however, while retracting, the smart coil unintentionally detached within the proximal end of the non-penumbra microcatheter.The physician, therefore, removed the microcatheter with the smart coil inside and then completed the procedure using a new microcatheter and new smart coils.There was no report of an adverse effect to the patient.
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