One 774f75 catheter with a 1.5cc syringe and a non-ew contamination shield were returned for examination.The reported event of broken pin was confirmed.As received, one pin in the thermal filament connector had broken and was not returned.The broken surface appeared uneven and rough.The error message "check thermal filament connection" was displayed on the lab vigilance ii monitor when the catheter was connected.The resistance value of thermal filament circuit was measured and found to be within specification.The balloon did not inflate.Leakage occurred form a hole of approximately 0.02" at the central area of the balloon.The balloon latex was relaxed, and the balloon edges did not appear to match at the damage location.All through lumen were patent without any leakage or occlusion.No visible damage was observed from the catheter body.A review of the manufacturing records indicated that the product met specifications upon release.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.It is standard 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, but can lead to complications such as infection or small infarction.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.In this case, there were no patient complications noted.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.
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