It was reported that a patient underwent an atrial fibrillation (afib) paraxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the bwi product analysis lab identified a hole on the pebax post-procedure.During the procedure, a force issue occurred.It was reported that during the operation, the force value could not be zeroed.A second device was used to complete the operation.There was no adverse event reported on patient.Force issue is not mdr-reportable.Hole in the pebax is mdr-reportable.
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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; however, during the analysis, sh force values were displayed and electrodes #3 and #4 were visualized black due to two open circuits found on the tip area.A manufacturing record evaluation was performed for the finished device 30960346l number, and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax could be related to the force issue reported by the customer; therefore, the customer complaint was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this can not be conclusively determined.It should be noted that product failure is multifactorial.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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