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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Event Description
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It was reported that it was unable to sense nor pace from the beginning of use after the swan ganz catheter insertion.The issue was resolved by replacing the catheter with a different lot number.Information such as what kind of surgery and examination the catheter was used for or if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.Date of event is unknown.
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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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Manufacturer Narrative
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The reported event of sensing and pacing issue was confirmed.Continuity testing found that a short condition occurred in the catheter body.Cut down was performed and revealed that the insulation of proximal lead wire was missing from under the proximal electrode to 2.4 cm from catheter tip.Insulation of distal lead wire was partially missing from under the proximal electrode to 2.5 cm from catheter tip.This condition allowed the leadwires to make contact and caused the short condition.After separating both wires, no short condition was observed, and continuous condition was confirmed between distal electrode and distal connector pin and between proximal electrode and proximal connector pin.The balloon inflated clear and concentric and remained inflated for 5min.Without leakage.No visible damage was observed from catheter body, balloon, windings, and returned syringe.Further evaluation regarding related quality issues is under investigation.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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Manufacturer Narrative
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Engineering evaluation was completed.A capa was initiated for this issue and a product risk assessment was met earlier.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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