One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.A non-edwards contamination shield was located on the catheter body from 61 cm proximal from tip to over the catheter tip.Original opened packaging box was returned with the unit.No introducer was returned.Attached non-edwards contamination shield was removed for evaluation.Balloon was found to be ruptured at the central area of the balloon latex.The ruptured edges of the balloon latex appeared to be different shapes and were not able to match up.All through lumens were patent without any leakage or occlusion.No other visible damage or inconsistency to the catheter body, balloon, or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.The customer report of balloon rupture issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.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.No corrective or preventative actions are required at this time.
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