Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, screening, temperature, impedance, and patency flow test of the returned device.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Temperature, impedance, and patency testing were performed per bwi procedures.The catheter temperature, impedance, and patency were working correctly and within specifications.No malfunction was observed.The force and high-temperature issues described were unable to be duplicated during the product investigation, however, the blood inside the pebax area found could be related to the reported issues.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.To minimize the temperature issue, the following guidelines should be followed.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If the temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.A manufacturing record evaluation was performed for the finished device and no internal action related to the reported complaint condition were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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