EDWARDS LIFESCIENCES SWAN GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION; ELECTRODE, PACEMAKER, TEMPORARY
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Model Number PE075F5 |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The reported event of pacing issue was unable to be confirmed.No visible damage or abnormality was observed from catheter body, balloon, windings and returned syringe.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 min.Without leakage.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.
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Event Description
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It was reported that a swan ganz had pacing failure from the beginning of use.It was unable to pace when inserted from the femoral vein.The external pacemaker was replaced but the issue was not resolved and the catheter was removed.It is unknown what kind of surgery or examination the catheter was used for, if the patient had cardiac conduction defect, or date of event.Patient demographic information was requested but unavailable.There were no patient complications reported.
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Manufacturer Narrative
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An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.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 a part of the monthly review.
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Search Alerts/Recalls
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