Model Number D97130F5 |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
malfunction
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Event Description
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It was reported in medwatch (b)(4) that there was a failure with the swan ganz bipolar pacing catheter, during use.The customer states the catheter would not pace during a transcatheter aortic valve replacement.There was no patient harm or injury.
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Manufacturer Narrative
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The swan ganz bipolar pacing catheter was returned for evaluation.The evaluation results confirmed the reported pacing issue.Continuity testing was performed and a full open condition of the distal circuit was found.The proximal circuit was continuous.An x-ray showed the distal lead wire was detached from the distal electrode.The proximal lead wire near the lumen port had cut into the catheter body.The balloon inflated clear and concentric and it remained inflated for five minutes without leakage.The device history record review is pending, the results will be submitted in a supplemental report.An engineering task has been assigned for further investigation.
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Manufacturer Narrative
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The engineering evaluation was completed.The pacing difficulty during use issue was confirmed through the product evaluation.Root cause could not be confirmed.As part manufacturing process, 100 percent of the units go through an electrical continuity inspection process.The ifu contains instructions on how to avoid damaging the catheter.Avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.A product risk assessment was generated for the intermittent condition at tip-distal electrode pacing catheter to cover full open and intermittent condition at tip for bipolar pacing catheters complaints incidence will continue to be monitored.Product evaluation confirmed a cut in the catheter body.In addition, 100 percent of the units go through a final inspection to the appearance of the unit.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing design defect.The device history record review was completed and all manufacturing inspections passed with no non-conformances.".
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Search Alerts/Recalls
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