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 in the splenic artery using pod6s.During the procedure, the physician successfully deployed and detached the initials pod coils in the target vessel using a non-penumbra microcatheter.While advancing a pod6 through the microcatheter, the physician experienced resistance and upon pushing further, the pod6 pusher assembly became bent; therefore, it was removed.The procedure was successfully completed using additional pod coils and the same microcatheter.There was no report of an adverse effect to the patient.
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