Results: the pet lock was slightly compressed at the proximal end of the pusher assembly but was intact.The pusher assembly had bends and kinks approximately 5.0 cm, 20.0 cm, 27.0 cm, 51.0 cm, 69.0 cm, 86.0 cm, 102.0 cm and 119.0 cm from the proximal end.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).Conclusion: evaluation of the returned ruby coil revealed the proximal pet lock was intact.If the pet lock is not broken, the pull wire could not retract allowing the embolization coil to detach.This may have occurred due to handle being improperly seated on the proximal end of the pusher assembly.During functional testing, a demonstration handle was used and the proximal pet lock was separated and the pull wire was retracted from the ddt.However, the embolization coil did not detach due to dried blood on the proximal constraint sphere.If the pull wire was retracted from the ddt during the procedure, the embolization coil would have likely detached from the pusher assembly.Further evaluation revealed bends and kinks along the pusher assembly.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.Please note that the following sections are being updated based on additional information provided by the sales representative on 01/07/2019: describe event or problem.This report is associated with mfr report number: 1.3005168196-2019-00033.
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