It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, the carto 3 system was displaying error 106: force sensor error when the catheter was connected to the patient interface unit.To troubleshoot, the cable was replaced without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.No patient consequences were reported.The force sensor error is not mdr-reportable.The 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.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned catheter revealed reddish material inside and a hole in the pebax.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device 31049633l, and no internal action was found during the review.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: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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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