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.
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while advancing a ruby coil through a non-penumbra microcatheter, the physician inadvertently bent the ruby coil pusher assembly.There was no resistance reported while advancing the coil.The ruby coil was removed and the procedure was then completed using a new ruby coil and the same non-penumbra microcatheter.There was no report of an adverse effect to the patient.
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