It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified that the edge of the pebax was separated from the electrode, causing internal parts to be exposed.During the procedure, the visualization of the smarttouch sf catheter was very erratic on the carto 3 system screen when on ablation.The cable was replaced without resolution.The smarttouch sf catheter was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.
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The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax and it was noted that the edge on the pebax was separated from the electrode, causing internal parts to be exposed.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no issues were observed.A manufacturing record evaluation was performed for the finished device 31185703l number, and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax could be related to the visualization issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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