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.Ingress testing resulted in fluid observed within the fiber cavities and within the shaft proximal to electrode 4, consistent with the failed shaft and irrigation leak tests and a loss of force data during the procedure.Further investigation revealed a break in the shaft material at the transition between the catheter shaft and electrode ring 4, consistent with fluid ingress within the catheter shaft proximal to electrode 4 and the failed shaft leak test.The pi irrigation tubing was noted to remain attached to metal irrigation tubing at the deformable body and no damage was noted to the irrigation tubing throughout the device.No tears in the shaft material under electrode ring 2 were detected, no leaks at the fiber optic seal were detected, no leaks from within the handle were detected, and no leaks were detected at the irrigation tubing transition near the deflectable portion of the catheter shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the failed irrigation leak test, the fluid ingress between electrodes 1 and 2, and the tear in the shaft material under electrode ring 4 remains unknown.There was a short circuit found between e2 and e4.When electrode ring 4 was removed to inspect for shaft damage beneath the electrode ring, it was noted that conductor wire 2 was fractured at the distal end of electrode ring 4.The short circuit between e2 and e4 was no longer detected following the removal of the electrode ring, indicating that the cause of the short circuit was the contact of the fractured conductor wire 2 with electrode ring 4.Conductor wire 2 was also noted to bulge under electrode ring 4, but it was determined that the conductor wire was not protruded or exposed under the electrode ring.The cause of the fracture in conductor wire 2 remains unknown; therefore, a product deficiency could not be confirmed.
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