Catalog Number 44038KA2 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
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Event Description
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The account alleges that during an interventional peripheral vascular procedure, a catheter tip detached within the patient.The physician used a vascular snare device to successfully externalize the foreign body liberating the patient's vessel.No additional patient consequences to report.
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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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