Model Number 407843 |
Device Problem
Material Separation (1562)
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Patient Problems
Foreign Body In Patient (2687); Foreign Body Embolism (4439)
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Event Date 12/07/2021 |
Event Type
Injury
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Event Description
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During the procedure, the introducer separated at the hub and a piece was left inside the femoral artery.The piece was retrieved successfully with a snare from the contralateral femoral artery.No complications were noted and there were no adverse consequences to the patient.
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Manufacturer Narrative
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One 5f ultimum introducer sheath was received for evaluation.The dilator was also returned.The reported event of sheath damage was confirmed.The sheath tubing had been torn and detached; the torn sheath tubing was returned.The cause of the sheath damage is consistent with damage during use.
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Manufacturer Narrative
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One 5f ultimum introducer sheath was received for evaluation.The dilator was also returned.The sheath tubing had been torn and detached at the hub; the torn sheath tubing was returned.The detached sheath tubing had been twisted, flattened, kinked and bent.The cause of the torn sheath tubing remains unknown.
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Search Alerts/Recalls
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