One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The catheter displayed contact force when connected to the tactisys quartz unit.The device did not meet specifications during a shaft leak test and an irrigation leak test.Additionally, multiple short circuits were detected.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, and loss of force data during the procedure.In addition, log file analysis indicated that contact force was lost upon insertion into the patient and was not regained.As a result of this finding, abbott is performing further investigation.
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