EDWARDS LIFESCIENCES SWAN GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY
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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 11/27/2023 |
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 catheter was unable to pace during use.The issue was resolved by replacing the catheter.Information including kind of surgery and examination the catheter was used for, the timing of when the pacing stopped, and if the patient had cardiac conduction defect were unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.
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Manufacturer Narrative
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A product evaluation was completed.The reported event of pacing issue was confirmed.Continuity testing confirmed a full open condition around catheter tip in the distal circuit.It was also confirmed that the distal circuit was continuous from just the proximal side of the proximal electrode to distal connector pin.The proximal circuit was found to be continuous.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 min.Without leakage.No visible damage or defect was observed from the balloon, windings returned syringe and catheter body.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was previously generated to cover the short condition for bipolar pacing catheters for product nonconformance with moderate, major, or critical severity.Additionally, a capa was generated to address the pacing difficulty failure effect for bipolar products with full open, intermittent, and short conditions and is in the closed phase.The root cause was related to manufacturing.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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