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 coil embolization procedure in the internal iliac artery (iia) using ruby coils.During the procedure, a ruby coil became bent as the physician was advancing it through the non-penumbra microcatheter, and therefore the ruby coil was removed.The procedure was then completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
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