Model Number PE074F5 |
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 device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 was unable to pace from the beginning of use after catheter insertion.The cable was replaced but the problem was not solved.The issue was resolved by replacing the catheter.Information such as what kind of surgery or examination the catheter was used for, if the patient had cardiac conduction defect, or date of event is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.
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Manufacturer Narrative
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The report of pacing issue was confirmed.Continuity testing found that the proximal circuit had an intermittent condition around the electrode, when flexing the tip area of the catheter.Distal circuit was continuous without any intermittent or open condition.No short condition was observed between the proximal and distal lead wires.A cut down was performed to isolate the intermittent condition and the intermittent condition was found to be around proximal electrode.The balloon inflated clear and concentric and remained inflated for 5 min.Without leakage.No visible damage was observed from windings, balloon and catheter body.Engineering evaluation was completed.A capa was initiated for this issue and a product risk assessment was needed.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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