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Lot Number CL12030 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported that during an irreversible electroporation ablation procedure using a faradrive sheath they were not able to clear bubbles during aspiration.The sheath was introduced into the patient and aspirated with no issues.The catheter was then inserted into the sheath and aspiration was performed again.This time air bubbles were seen during aspiration, and repeated aspiration did not clear the air out of the catheter.The catheter was removed, and the sheath was once gain successfully aspirated.The catheter was re-introduced and once again there were bubbles that could not be cleared during the aspiration.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.
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Search Alerts/Recalls
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