E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the smart touch bidirectional sf device was returned to biosense webster (bwi) for evaluation.A visual inspection and temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed that there was a reddish material inside the pebax and a rupture on the surface of the tip area.The temperature and impedance test was performed, and a high temperature was displayed.The rupture at the pebax could be related to the issue found and the issue reported by de customer.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30991521l 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 (ifu) contain the following recommendations: in the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn, and the tip electrode inspected for coagulum before rf energy is reapplied.In order to prevent damage to the catheter tip, use the insertion tube supplied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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