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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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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 preparation for a pulse field ablation (pfa) procedure to treat paroxysmal atrial fibrillation a faradrive steerable sheath clear was selected for use.The sheath was prepared per the instructions for use (ifu).The sheath was flushed with no abnormalities, but when aspiration was performed with the sheath fully submerged a very large component of air was drawn into the syringe.Air was clearly visible in the luer tubing as well.Further forward flushing was performed along with light agitation of the proximal end of the sheath as part of troubleshooting, though the air bubbles continued to appear when aspiration was performed again.The 3-way tap on the sheath was manipulated to ensure air was not entering from there, but air bubbles were still present in the tubing during aspiration.Another aspiration was attempted with the valve covered, but bubbles were again present.The sheath was replace and the procedure was completed.No patient complications were reported.The device is expected to be returned for analysis.
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Search Alerts/Recalls
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