FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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Lot Number 0008021497 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure a farawave pulsed field ablation catheter was selected for use.When preparing the catheter, a white powder was noticed on the handle.The physician decided to clean the catheter and use it.After successfully ablating the left pulmonary vein, the physician moved to the right inferior pulmonary vein and when tried to deploy the catheter a spline inversion occurred.Manual troubleshooting did not solve the issue, so the catheter was replaced.The procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory 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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