No product was returned for evaluation; the device was discarded by the dealer.Without the return of the product, it is not possible to determine if damages or defects existed on the product.A device history record review was completed and documented that device met all specifications upon distribution.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.It is unknown if user or procedural factors may have contributed to the event.A broken/separated pa catheter has the potential to embolize in the patient.In this case, the patient pulled on the catheter until the device broke.A broken catheter has the potential to embolize and therefore the risk to patient is not considered remote.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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