The lot number for the device were provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation was unconfirmed for the reported inflation issue, deflation issue and twisted inflation port.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that the model cq7584 pta balloon dilatation catheter allegedly had an material twisting, inflation issue, and unable to deflate.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was (b)(6) years old male, weighed (b)(6) lbs.
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