The lot number was provided and a lot history review was performed.The sample was returned and the investigation confirmed for frayed fibers, peeling pebax, unraveled fibers, and uneven inflation.The definitive root cause could not be established.The device is labeled for single use.(b)(4).
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This report summarizes one malfunction.A review of the reported information indicated that model at75124 pta balloon dilatation catheter allegedly experienced material frayed, inflation issues, peeled layer, and unraveled material.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
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