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 into the patient.
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The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils.During the procedure, a ruby coil broke within the non-penumbra microcatheter.The physician therefore flushed the ruby coil into the target location in the patient, and the procedure ended at that point.There was no report of an adverse effect to the patient.
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