It was reported that during use, this swan-ganz bipolar pacing catheter was inserted through the sheath into the heart of the patient to pace, but the catheter would not capture and pace.A new catheter was inserted, and it captured.The patient was transferred to the intensive care unit (icu) after a quick stop for a computed axial tomography (cat) scan.After the patient was in the icu room the new catheter stopped capturing and the patient was returned to the catheterization laboratory and another catheter was placed.It immediately captured and the patient was again returned to the icu.Follow up attempts were made to the customer regarding any patient injury or the status of the patient but there was no response.The device will not be returned for evaluation as it was discarded at the facility.Without the 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.A device history record review was completed and documented that device met all specifications upon distribution.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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