The patient was undergoing an abdominal aortic aneurysm (aaa) repair and a coil embolization procedure using a pod4.During the procedure, the physician experienced resistance while repositioning the pod4.While removing the pod 4 with continued resistance, the physician noticed it was only attached to the pusher assembly by a thin wire.The procedure continued without a coil embolization.There was no report of an adverse effect on the patient.
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Conclusion: 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.Device was disposed of by the hospital.
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