It was reported in a journal article that a (b)(6) year old female patient with acute decompensated heart failure, severe pulmonary hypertension, and atrial fibrillation on anticoagulation had a pulmonary artery catheter inserted for hemodynamic monitoring.Subsequently, the patient developed acute hemoptysis and damped pulmonary artery pressure waveforms during inflation of the catheter tip balloon.The possibility of pulmonary artery rupture was immediately recognized and confirmed with ct angiogram of the chest.Emergent interventional radiology guided coil embolization of pulmonary artery rupture and pseudoaneurysm was successful.The patients hospital stay was unremarkable and she was discharged home with no re-bleeding, confirmed by repeat ct scan of chest.
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This event is from a journal article that is 2 years old and the product will not be returned.The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.Vessel perforation/damage may occur as a result of suturing the pulmonary artery catheter into a surrounding structure.In this case, the patient¿s hospital stay was unremarkable, and she was discharged home with no re-bleeding, confirmed by repeat ct scan of chest.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Please note the initial medwatch was sent before all information was entered.
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