The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a hole and 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.An ablation cycle could not be performed since no temperature was displayed on the generator.The blood found inside the pebax area may contribute to the force and temperature issue however the temperature issue is unrelated to the reported event.A manufacturing record evaluation was performed for the finished device 30793117m number, and no internal action was found during the review.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.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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