The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.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.These catheters are typically inserted in patients who are either bradycardic or are undergoing a diagnostic procedure and need to be temporarily paced.They can also be placed emergently when a patient is experiencing hemodynamic instability.Therefore, problems with the catheter could lead to a delay in pacing, causing prolonged periods of bradycardia or hypotension, which has the potential to be associated with poor patient outcomes.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.No corrective actions will be taken at this time.
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