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.As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for peeling / delaminated and unconfirmed for material rupture.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
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