A patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab identified reddish mateiral in the pebax, indicative of a possible hole.The finding was identified on (b)(6) 2022.During the procedure, the carto 3 system displayed a high force reading when they came on ablation.The catheter was exchanged and the issue was resolved and the case was completed.No patient consequences were reported.High force is not mdr-reportable.Hole in the pebax is mdr-reportable.
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The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed reddish material in the pebax.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Scanning electrode microscope analysis shows evidence of mechanical damage and a hole on the pebax surface.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed for the finished device 30837377l number and no internal action was found during the review.The force issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturers reference number: (b)(4).
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