Related manufacturing ref: 2182269-2023-00032.During a supraventricular tachycardia procedure, there was signal interference which resulted in a delay.The catheter was replaced, but there was still signal interference, so the catheter was replaced again which resolved the issue and procedure was completed.
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One 4mm tip, large curl, safire ablation catheter was received for evaluation.The results of the investigation concluded that electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported noise remains unknown.
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