The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a cut on pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue.Then the device was tested, the generator test was performed the temperature and impedance test was verified, and the device was found working correctly.No temperature or impedance issues were observed, for flow the catheter was irrigated correctly, and no liquid leakage was detected during the analysis.A manufacturing record evaluation was performed for the finished device 30697920l number, and no internal actions related to the complaint were found during the review.The customer complaint regarding the temperature issue was unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The (ifu) instructions for use contain the following recommendations: if temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.The irrigation system must be rechecked before restarting rf delivery.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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