The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation. visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material occluding the irrigation holes and a hole in the surface of the pebax.Due to the occlusion condition, a cool flow pump and pressure gage test was performed, but the device failed the specifications.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications; however, during the analysis, no temperature and impedance were displayed due to open circuits in the tip area.A manufacturing record evaluation was performed for the finished device 30950291m number, and no internal actions related to the reported complaint condition were identified.The failure observed with the pebax could be related to the force issue reported; therefore.The customer complaint was confirmed.It should be noted that product failure is multifactorial.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.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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