FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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Lot Number 0008021668 |
Device Problems
Positioning Failure (1158); Entrapment of Device (1212); Material Integrity Problem (2978); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
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 a procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.After ablation of the right superior pulmonary vein (rspv) was completed and an attempt was made to cannulate the left superior pulmonary vein (lspv) with the catheter, a spline inverted and the array took on a cobra shape.When the catheter was removed from the patient to correct the inversion, the deployment slider on the handle broke.Afterwards, the boston scientific starter j guidewire became trapped in the catheter and would not advance or retract.It was also not possible to move the catheter array from the flower to the basket shape, nor open or close the array.The catheter was replaced 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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