The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed foreign material and a hole in the surface of the pebax.The device was connected to the carto 3 system and it was recognized and visualized correctly.No icon issues were observed.The failure observed in the pebax could be related to the wrong manipulation of the device during the procedure and to the issue reported by the customer; however, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device 30959009l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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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