Related manufacturer report number: 3008452825-2023-00548.During an atrial fibrillation procedure, temperature increases were noted with the tactiflex ablation catheter inhibiting ablation, resulting in a delay.The issue persisted despite changing catheter orientation/anatomic location, removing the catheter, re-flushing, and power cycling the ampere generator.Additionally, the ampere generator, cool point pump, cool point pump tubing set, and tactisys quartz system were replaced, but with no resolution.The tactiflex ablation catheter was replaced for a second tactiflex ablation catheter but the same issue occurred again.The tactiflex ablation catheter was replaced again for a third tactiflex ablation catheter and the issue was resolved.The procedure was completed successfully with no adverse consequences to the patient.
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One uni-directional, curve d, tactiflex ablation catheter, sensor enabled was received for evaluation.The reported temperature increase issue was confirmed.A simulated ablation was performed and no temperature or power delivery anomalies were noted.Further inspection of the distal electrode indicated the tip thermocouple was inadequately bonded within the distal tip well, consistent with the reported event.The catheter met specifications during electrical testing and irrigation flow testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Abbott is continuing to monitor this issue.
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