The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400s (pc400), px slim delivery microcatheter (px slim), and a non-penumbra embolization device.During the procedure, the physician placed a px slim behind the embolization device and placed two pc400s in the aneurysm.While advancing another pc400 as the third coil, the physician experienced resistance inside the aneurysm from the packing density of the previously placed pc400s.The physician then pulled the pc400 in an attempt to remove it; however, the pc400 had unintentionally detached with approximately five centimeters of the pc400 in the aneurysm and the rest of the coil was within the microcatheter.Subsequently, while pulling the pc400, the coil became stretched.Therefore, the physician used a snare device to remove the remaining pc400 out of the microcatheter and aorta; then used aspiration to successfully remove the remaining pc400.The physician decided to end the procedure at this point due to access with the px slim was lost.There was no report of an adverse effect to the patient.
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