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.The device was implanted in the patient.
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern).A ruby coil then unintentionally detached within the lantern as the lantern backed in to the non-penumbra sheath.The physician attempted to remove the lantern with the ruby coil inside, however the ruby coil remained in the sheath; therefore, the physician pulled out the ruby coil using his fingers.As the ruby coil was being pulled out, the coil broke into two pieces.The physician removed one piece, and the second piece flowed into the target location; therefore, it was left in place.The procedure ended at this point.There was no report of an adverse effect to the patient.
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