Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.No actions will be taken at this time.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 are well described in the literature.Balloon deflation difficulty can result in an occlusion of blood flow and possible distal ischemia.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.(b)(4).
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It was reported that during use, after passing the catheter through the pulmonary artery, the balloon on the swan-ganz catheter did not deflate.Unfortunately no further information is available to clarify if the syringe was attached to the gate valve during the deflation attempt.There was no allegation of patient injury.Patient demographics were requested and not provided.The device was not available for evaluation due to contamination.
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