(b)(4).Correction: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.Correction: the date received by manufacturer was reported on the initial mdr as 12/03/2015; however, subsequent information received stated the correct date was 12/08/2015.It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the reported balloon rupture could not be determined.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.
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