The product investigation was completed.Device evaluation details: the device was returned for evaluation.The returned device's visual inspection and screening tests were performed following biosense webster (bwi) procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No malfunction was observed.The events described were unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.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 the tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.A manufacturing record evaluation was performed for the finished device 31020298l number, and no internal actions related to the complaint were found during the review.Biosense webster¿s quality process ensures all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, corrective action and preventive action (capa) activity was not required.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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