The lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.Based on the investigation of the returned catheter sample neither a difficult deployment nor an expansion failure could be confirmed.The catheter sample was returned in released but good condition so that an indication for an expansion issue or difficult deployment could not be identified.Images documenting difficult deployment or expansion issue during deployment have not been provided.The alleged issue could not be re-produced which led to an inconclusive evaluation result.A definite root cause for the reported event could not be determined.The device is labeled for single use.
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