The patient was undergoing a coil embolization procedure to treat a cavernous aneurysm using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through a non-penumbra microcatheter, the physician noticed that the smart coil pusher wire was kinked; therefore, it was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
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Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was lost in transit and is no longer available for return.Therefore, 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 lost in transit.
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