Catalog Number 510038CB2-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 01/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is not expected to be returned for evaluation.A follow-up report will be submitted once the investigation is complete.
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Event Description
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The account alleges that during an embolization procedure, the tip of the catheter detached within the patient's artery.The clinician successfully removed the detached pieces using a snare 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.Video was received.The complaint is 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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