The product investigation was completed.Device evaluation details: visual analysis revealed a hole on the surface of the pebax.The pebax was observed on the microscope and it was found evidence of a hole, stress marks and mechanical damage.It is possible that the damage was generated with an unknown object.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device 30792657m number, and no internal actions related to the reported complaint condition were identified. 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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