Our product evaluation laboratory received one swan-ganz catheter with calcup, monoject limited volume syringe, and contamination shield.The balloon was found to have a tear at the proximal end of the distal bond, extending around most of the circumference of the balloon.The edges of latex did not appear to match at the torn site.All through lumens were patent without any leakage or occlusion.No visible damage was observed on the returned syringe, contamination shield or calcup.A device history record review was completed and documented that the device met all specifications upon distribution.Report of "the balloon of this swan-ganz catheter was found broken" was confirmed.An engineering evaluation was initiated to assess any manufacturing-related processes which could be correlated to the complaint.No root cause could be determined.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.(b)(4).
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