Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole on the surface of 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.Although no force or issues were observed during the test, the damage observed on the pebax could be related to the force issue reported during the procedure; however, this cannot be conclusively determined.Due to the findings during the analysis, the force issue reported by the customer was confirmed.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 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, and no internal actions related to the reported complaint were identified.As part of biosense webster¿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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