It was reported that the procedure was performed to treat a lesion in the heavily calcified and moderately tortuous left anterior descending (lad) artery.The target lesion was prepared using a non-abbott cutting balloon.The 3.5 x 12 mm nc trek was prepared without issue, advanced, inflated and deflated at the target lesion; however, after removal of the device, a fiber was noted on the balloon.The site cannot confirm if the balloon came in contact with any procedure material that could have left the fiber on the balloon.No additional information was provided.
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The device was returned for analysis.The reported device contamination was not confirmed, as there was no fiber contamination found on the balloon as reported.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported contamination problem.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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