Catalog Number 510038VER-H/CN |
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 10/10/2023 |
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 will be submitted when the investigation is complete.
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Event Description
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The account alleges that during the iliac arteriography procedure, the catheter tip cracked and separated within the patient.The clinician successfully removed the detached pieces using a capture device.No additional patient consequence to report.
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Manufacturer Narrative
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The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
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Search Alerts/Recalls
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