One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Optical fibers 1 and 2 no longer met specifications for optical properties and no contact force was displayed when the returned device was 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, observed short circuits, and a loss of force data during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the detached pi irrigation tubing was determined to be supplier related.Abbott is continuing to monitor the reported issue.
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