Catalog Number 28MC24130ST/D |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
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 evaluation is complete.
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Event Description
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The account alleges that during a celiac artery embolization while attempting to manipulate the microcatheter within the patient, the radiopaque marker band detached within the patient's tortuous anatomy.The physician successfully externalized the foreign body with a vascular snare device liberating the vessel.The embolization procedure was completed without additional consequences to the patient.
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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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