One 65 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.Further investigation revealed the shaft had been bent at the distal edge of electrode ring 4, and fluid ingress was noted proximal to electrode ring 3.Conductor wire 3 was determined to have fractured at the location of the bend, allowing fluid ingress into the shaft under electrode ring 4.In addition, the irrigation tubing was noted to be damaged at the location of the bend in the shaft, consistent with the observed fluid ingress, the failed shaft leak test, the failed irrigation leak test.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend in the shaft, and resulting fluid ingress, failed leak tests, and shaft damage remains unknown.
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