Model Number 406868 |
Device Problem
Fracture (1260)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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At the end of the procedure, a tear was noted in the body of the sheath when removed from the patient.There were no consequences to the patient.
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Manufacturer Narrative
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One 8.5f fast-cath introducer sheath was received for evaluation.The sheath had been torn and stretched; the torn sheath material remained attached.No anomalies were noted when a dilator from current inventory was inserted through the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported damage remains unknown.The cause of the sheath tear is consistent with damage during use.
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Search Alerts/Recalls
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