As the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported balloon rupture, material deformation, peeling and delamination and material split.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(device - 4008).
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This report summarizes one malfunction.A review of the reported information indicates that model dr8074 pta balloon dilatation catheter allegedly experienced material deformation, material rupture, peeled and material split.The information was received from a single source.One patient was involved with no reported patient injury.Female patient's age and weight were not provided.
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