During preparation for a coil embolization procedure, the physician noticed that a penumbra smart coil (smart coil) would not advance through and exit out of its introducer sheath.It was reported that the physician attempted to advance the smart coil into a bowl of saline but the smart coil was stuck in its introducer sheath.The issue with the smart coil occurred prior to use and, therefore, it was not used in the procedure.The procedure was completed using another smart coil.
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Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.After the introducer sheath was removed from its pusher assembly a neckdown zone distal to the friction on the sheath was noticed.Upon functional testing, resistance was encountered while attempting to advance the returned smart coil from its returned position and the smart coil could not be advanced any further.The introducer sheath was removed from its pusher assembly by the penumbra investigator.The smart coil was re-sheathed, and the embolization coil was able to be advanced and retracted through its introducer sheath without an issue.Conclusions: evaluation of the returned smart coil confirmed the difficulty experienced when attempting to advance the coil.Further evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the pusher assembly mid-joint is retracted to beyond its original position proximal to the introducer sheath friction lock, resistance may be encountered during advancement.After unseating the mid-joint from the friction lock, the smart coil was able to advance through a demonstration microcatheter without issue.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.H3 other text : placeholder.
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