The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the distal end of a ruby coil pusher assembly became kinked as the hospital staff was advancing it out of the introducer sheath and into a lantern delivery microcatheter (lantern).The ruby coil was, therefore, removed, and the procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.
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Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly and the coil was undamaged.The pusher assembly was kinked approximately 20.0 cm, 39.0 cm, 57.0 cm, 78.0 cm, 105.0 cm and 107.0 cm from the proximal end.The coil was able to be advanced out of its introducer sheath and through a demonstration microcatheter without any issue.Conclusions: evaluation of the returned device revealed there were kinks along the length of the pusher assembly.If the device is forcefully advanced against resistance, the pusher assembly may become kinked.Further damage to the pusher assembly may have occurred during packaging for return to penumbra.During functional testing, the returned ruby coil was able to be advanced through a demonstration microcatheter without an issue.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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