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 in the splenic artery using ruby coils.During the procedure, the physician felt resistance while advancing a ruby coil through the non-penumbra microcatheter and, consequently, the pusher assembly of the ruby coil became kinked.The ruby coil was, therefore, removed, and the procedure was completed using additional ruby coils, pod coils, pod packing coils, and the same microcatheter.There was no report of an adverse effect to the patient.
|