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Model Number 00801902026804 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that there was significant bleeding after inserting the sheath.The surgeon placed the sheath in anticipation of inserting the iab post bypass run.As a result, the sheath was capped by the surgeon to control the bleeding.Iab therapy was not required, so the sheath was removed.There was no report of delay in therapy.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint for sheath leaked is confirmed.The returned teflon sheath was noted with a leak from the sheath seal during functional testing.During inspection, the sheath seal was found damaged with a small leak site.The root cause of the complaint is undetermined.The complaint is isolated.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that there was significant bleeding after inserting the sheath.The surgeon placed the sheath in anticipation of inserting the iab post bypass run.As a result, the sheath was capped by the surgeon to control the bleeding.Iab therapy was not required, so the sheath was removed.There was no report of delay in therapy.There was no report of patient complications, serious injury, or death.
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Search Alerts/Recalls
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