Model Number 00884450009420 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/24/2022 |
Event Type
malfunction
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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 vascular prosthesis procedure the catheter tip cracked and detached within the left iliac artery following insertion.Retrieval of the foreign body was attempted using the right femoral artery, but was unsuccessful.The foreign body was covered by the leg of the abdominal aorta coated stent and it was decided an additional retrieval procedure was not needed.No additional patient consequence 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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