Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned device revealed that the ruby coil was fractured.This type of damage typically occurs due to improper handling during removal from packaging.If the device is forcefully retracted at an extreme angle during removal from packaging the pusher assembly may become kinked, subsequently, if the kinked pusher assembly is attempted to be straightened, damage such as this may occur.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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During preparation for medical procedure, the hospital staff found that the ruby coil was kinked at detachment zone while removing the ruby coil from its packaging.Kinked ruby coil was found prior to use and therefore, the ruby coil was not used in the procedure.The procedure was completed using a new ruby coil.
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