It was reported that the procedure was to treat a mildly calcified, mildly tortuous right coronary artery.The 4.50x8mm nc trek balloon dilatation catheter would not deflate properly post inflation.Additionally, it was noted that it was difficult to remove from the guide catheter.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
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Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be 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 deflation issue; however, the reported difficulty removing the device 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 the device.G2: user facility removed.
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