A visual inspection was performed on the returned device and the reported balloon rupture and balloon separation were confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.There was no damage noted to the balloon catheter during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported balloon rupture, difficulty to remove and balloon separation and noted damages appear to be related to the operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.Exemption number e2019001.
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