One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The device did not meet specifications during a shaft leak test and an irrigation leak test.In addition, multiple short circuits were detected during electrical testing.Further investigation revealed a leak at the irrigation tubing and tip assembly junction due to the pi irrigation tubing detaching from the metal irrigation tubing, consistent with the failed shaft and irrigation leak tests, fluid ingress, observed short circuits, a loss of force data during the procedure, and the reported issues.Electrodes 1-4 met specifications for continuity during electrical testing with no open circuits detected.The root cause of the pi irrigation tubing detachment was determined to be supplier related.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
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