The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed for peeling but is unconfirmed for inflation issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the conquest pta dilatation catheter products that are cleared in the us.The pro code for the conquest pta dilatation catheter products is identified.
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