The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed a hole with reddish material was observed.The potential cause of the damage on the pebax could be related to the procedure.A manufacturing record evaluation was performed for the finished device [31085863l] 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.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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It was reported that a patient underwent an atrial flutter (afl) 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 physician noticed blood within the clear, distal tip of the catheter where the force spring is located.The catheter was exchanged and the procedure continued.There were no difficulties with inserting or removing the catheter, and no damage to the catheter was noted at the time.No patient consequences were reported.The blood in the tip is not mdr-reportable.The hole in the pebax is mdr-reportable.
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