Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the guide wire; however, the reported separation appears to be related to circumstances of the procedure.Factors that may contribute to the difficult to remove the balloon dilatation catheter from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.Furthermore, it is possible that the balloon separated during removal as resistance was encountered with the guide wire.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6- medical device problem code 2017 was removed.
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