The catalog number identified has not been cleared in the us, but is similar to the conquest pta dilatation catheter that are cleared in the us.The product classification code for the conquest pta dilatation catheter product is identified.The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed for inflation problem, material rupture, peeled/delaminated.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model cq75104j pta balloon dilatation catheter allegedly experienced deflation problem, material rupture and peeled/delaminated.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
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