Our product evaluation laboratory received one swan-ganz catheter with attached 1.5 cc limited volume syringe.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without the returned syringe attached, which is within specifications.As stated in the ifu, ¿passively deflate the balloon by removing the syringe from the gate valve¿.The balloon failed to deflate fully with the returned syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or returned monoject 1.5cc limited volume syringe.A device history record review was completed and documented that the device met all specifications upon distribution.The report of "balloon of this swan-ganz catheter did not fully deflate" was not confirmed, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No actions will be taken at this time.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.The duration of catheterization should be the minimum required by the patient¿s clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.It is unknown if user or procedural factors contributed to this event.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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As reported, prior to use in the patient, the balloon of this swan-ganz catheter did not fully deflate.The customer could not confirm if the syringe was attached while trying to deflate the balloon.There was no allegation of patient injury.Patient demographics requested, but not provided.
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