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 hospital disposed of the device.
|
The patient was undergoing a coil embolization procedure using pod4's.During the procedure, the hospital staff noticed that proximal end of the pusher wire of a pod4 was bent as the pod4 was beginning to be advanced through a non-penumbra microcatheter.The pod4 was therefore removed, and the procedure was completed using additional ruby coils.There was no report of an adverse effect to the patient.
|