It was reported that the procedure was performed to treat a target lesion in an unspecified vessel.During advancement, resistance was noted.Mild force was applied and the balloon dilatation catheter separated into 2 pieces, at a location outside the patient anatomy.The separated segments were easily removed from the guide wire.There was no adverse patient effect or clinically significant delay.No additional information was provided.
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Visual and dimensional inspections were performed on the returned device.The reported separation was confirmed; however, the reported difficulty advancing the device could not 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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty advancing the device; however, the reported separation appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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