No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.
|
During anesthesia induction for cardiac surgery, it was reported that a swan ganz catheter was inserted through a 9fr.Introducer into the right internal jugular vein.Post insertion, intratracheal bleeding was observed.Surgery was stopped.An aneurism and bleeding in the right pulmonary artery were confirmed by ct scan.Post-op the patient was noted to be in stable condition.The device was discarded at the hospital.
|