Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly and knotted in two locations.The embolization coil had dried blood on it.The smart coil¿s embolization coil was knotted in two locations and the pusher assembly was kinked.Therefore, the smart coil could not be functionally tested through a demonstration microcatheter.Conclusions: evaluation of the returned device confirmed that the smart coil was knotted in two locations.However, the root cause of the smart coil being knotted could not be determined.Further evaluation of the returned device revealed that the embolization coil had dried blood on it.The complaint stated that the device was not used in the procedure and, therefore, the root cause of the dried blood on the embolization coil could not be determined.Further evaluation of the returned device revealed that the smart coil pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occur while packaging the device for return to penumbra.The smart coil's introducer sheath was not returned 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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While preparing a new penumbra smart coil (smart coil) for a coil embolization procedure, the hospital staff noticed that the coil was knotted upon removal from the packaging hoop.The damaged smart coil was found prior to use and therefore, was not used in the procedure.The procedure was completed using an additional coil.
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