Model Number PE075F5 |
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 an unknown issue was observed with this swan ganz bipolar pacing catheter during use.There were no patient complications reported.Per follow up with rep, it was reported that the catheter was unable to sense an intrinsic electrical signal during use.Background of malfunction occurrence, phase when the catheter got unable to sense, what kind of surgery and examination the catheter was used for, whether the patient had cardiac conduction defect or whether the catheter was replaced are unknown.Patient demographic information was requested but unavailable.
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Manufacturer Narrative
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The reported event of sensing issue was confirmed.Continuity testing found that a short condition occurred between the proximal and distal circuits in the y adaptor.No open or short condition was observed in the lead wires between distal side of y adaptor and the electrodes.No visible damage was observed from catheter body, balloon, and windings.The balloon inflated clear and concentric and remained inflated for 5min.Without leakage.Further evaluation regarding related quality issues is under investigation.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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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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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 short condition at the y adaptor between proximal and distal lead wires for bipolar pacing catheters for products nonconformance with moderate, major, or critical severity.Corrections to the h6 codes investigation findings and investigation conclusions were made.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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