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 Date 06/23/2022 |
Event Type
malfunction
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Event Description
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It was reported a swan ganz pacing catheter was unable to pace from the beginning of use after the catheter insertion and connecting the catheter to a generator.The issue was resolved by replacing the catheter with a different lot number.The catheter was used for percutaneous coronary intervention.The patient did not have any cardiac conduction defect.Patient demographic information was requested but unavailable.There were no patient complications reported.
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Manufacturer Narrative
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The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.The lot number was not provided thus a device history record was not reviewed.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 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 2.2 cm from catheter tip.Insulation of distal lead wire was partially missing from under the proximal electrode to 2.3 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 supplier related quality issues is under investigation.Lot number was obtained through return of product.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 needed.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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