For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation confirmed for the reported balloon rupture, as a pinhole rupture was noted to the balloon, additionally the investigation also confirmed for the identified peeling pebax.The definitive root cause for the balloon rupture and peeled pebax could not be determined based upon available information.The device is labeled for single use.
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This report summarizes one malfunction.A review of the malfunction indicated that model cqf7554 pta balloon dilatation catheter allegedly peeled and experienced material rupture.This report was received from one source.This event involved a patient with no patient consequences.Age, weight, and gender were not provided for this patient.
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