The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: upon receipt, the catheter was visually inspected and it was found a hole at the pebax and reddish material inside it.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly, the force values were observed within specifications.A manufacturing record evaluation was performed for the finished device 30419882m number, and no internal actions related to the reported complaint condition were identified.The customer complaint regarding force issue was unable to duplicate during the product investigation however, the reddish material found inside the pebax area could be related to the reported issue.The root cause of the hole at pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
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