The device was not returned for evaluation.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.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a mildly tortuous, mildly calcified de novo mid left anterior descending artery that was 75% stenosed.A 2.75x15mm traveler balloon was advanced to the lesion and inflated once at 12 atmospheres (atm).However, when attempted to be deflated with negative pressure being applied for 30 seconds, it was slow to deflate.The balloon took one minute to complete deflation and was then simply removed.Afterwards, the procedure was successfully completed with a non-abbott device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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