Catalog Number 57538CARN10 |
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 08/04/2022 |
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 the procedure, while passing the catheter from the right iliac artery to the left iliac artery, the catheter fractured.The radiopaque distal segment detached from the rest of the catheter.The detached piece was successfully retrieved using a capture loop.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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