The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.A screening test was performed and the device was recognized and visualized correctly; however negative force vector appeared in the system with high force readings.The device was further analyzed for insufficient adhesive on the tip area.A manufacturing record evaluation was performed for the finished device (b)(6).Number, and no internal actions related to the reported complaint condition were identified.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The root cause of the damage observed in the pebax could be related to the excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.The instructions for use (ifu) contain the following recommendations: in order to achieve optimal force reading accuracy and stability, allow the catheter to warm up for 2 minutes after connection to the carto¿ 3 system, prior to use of the force feedback feature.Zero the contact force reading when moving the catheter from one chamber of the heart to another or upon reinsertion.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 reference number: (b)(4).
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