Catalog Number PID6F11018NTPD/C |
Device Problems
Fracture (1260); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2023 |
Event Type
Injury
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Event Description
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The account alleges that the guidewire frayed and became caught within the patient's anatomy.
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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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Manufacturer Narrative
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The suspect medical device was not returned for investigation.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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