Catalog Number 512535VER |
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 11/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.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 diagnostic neuro angiogram procedure, the catheter tip detached within the patient.The physician used a vascular snare device to successfully remove the foreign body from the patient with no additional patient consequences 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.Should the device return at a later date, the investigation will be re-opened.
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Search Alerts/Recalls
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