One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Electrodes 1-4 met specifications during electrical testing with no open circuits detected.However, multiple short circuits were detected, consistent with the reported signal issue and impedance issue.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle, consistent with the reported leak.In addition, dried saline was noted within the connector plug, consistent with the short circuits detected.Further testing revealed a leak at the luer/irrigation tubing junction due to a gap in the adhesive between the irrigation tube and the proximal tube inside the luer lock, allowing fluid to flow outside of the irrigation tubing and into the proximal tubing.This is consistent with the dried saline noted within the connector plug.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The gap in the adhesive between the irrigation tube and the proximal tube inside the luer lock was determined to be supplier related.
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