EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number 123F6P |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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One 123f6 with 1ml syringe barrel was returned for evaluation.The reported issue of deflation difficulty was unable to be confirmed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached.Per ifu, passively deflate the balloon by removing the syringe from the gate valve.Balloon deflation time was within specification.Max.Deflation time from full capacity is 4 seconds per eas556 rev bp without a syringe attached.Distal lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.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 the balloon did not deflate.This was before use in a patient, during device prep.The nurse tried to deflate the balloon after detaching the syringe, but it would not deflate completely.She inflated it again and removed the syringe, but it would still not deflate.There is no patient involvement.
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Manufacturer Narrative
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The issue of balloon deflation difficulty was not confirmed.The failure mode could not be confirmed to be associated with a manufacturing/design defect.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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