Catalog Number EN2007030/CNB |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/24/2021 |
Event Type
malfunction
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Event Description
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The account alleges that during a vascular procedure involving a snare device, when retrieving the vascular snare from within the catheter, they also retrieved some type of transparent foreign material as well.It is currently unknown if any of the foreign material had been inadvertently introduced into the patient during use.The material in question is not radiopaque.The patient was discharged as expected with no additional consequences to report.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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