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Lot Number CL12135 |
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 03/19/2024 |
Event Type
malfunction
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Event Description
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Pf114 faradise clinical study, subject id: (b)(6).It was reported that during preparation for an irreversible electroporation ablation procedure using a faradrive sheath there was air seen during aspiration.They exchanged the sheath, prior to use in the patient, 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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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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Search Alerts/Recalls
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