Model Number 12TLW405F35 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event of inflation and deflation difficulties were confirmed.The balloon was inflated with 1.7ml air and the balloon inflated concentric and did not leak.However, resistance was felt when inflating the balloon with di water.Balloon could not be deflated completely after 15 seconds by pulling back on syringe plunger.Balloon deflation time was out of specification.Max.Deflation time from full capacity with water is 15 seconds.Cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal windings.Balloon latex, bushings and windings were intact.Through lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.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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Event Description
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It was reported that a fogarty catheter had inflation and deflation difficulties.Event occurred during prep and before procedure.Catheter was exchanged with a second catheter.No patient involvement.Per follow up with customer, the balloon was able to deflate.
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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 addresses the balloon deflation issues for the 5.5 thru lumen models, and a capa to address this issue is currently in its implementation phase.Based on the provided information and investigation, the potential root cause is related to inadequate process in manufacturing.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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