The patient was undergoing a coil embolization procedure in the left middle cerebral artery (mca) using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance while attempting to advance the first coil, a pc400, through its introducer sheath and was unable to advance the pc400 beyond its starting position.The pc400 was therefore removed and was not used in the procedure.The procedure was completed using another pc400 and the same px slim delivery microcatheter (px slim).There was no report of an adverse effect to the patient.
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Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had bends approximately 12.0 cm, 23.0 cm and 40.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The pet bump on the pull wire was distal to the ddt.The proximal end of the embolization coil was within the introducer sheath.The embolization coil was compressed, and offset coil winds were present along the length of the coil.During functional testing, resistance was encountered while retracting the pc400 into the introducer sheath and the embolization coil became more compressed.Strong resistance was encountered while advancing the pc400 and the device could not advance out of its introducer sheath.Conclusions: evaluation of the returned pc400 revealed offset coil winds.If the introducer sheath is not seated properly within the hub of its parent catheter, resistance may be encountered while advancing.If the device is forcefully advanced against this resistance, damage such as offset coil winds will likely occur.This damage likely contributed to the reported inability to advance the coil during the procedure and functional testing.Further evaluation revealed the pull wire was distal to the ddt.This was also likely a result of forcefully advancing the device against resistance.The bends on the returned device were likely incidental to the reported complaint.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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