(b)(4).Additional method: device history record for lot (14fe26) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.One actual sample was returned for investigation.Based on observation the balloon of the sample was split.A simulation test was conducted with representative samples from production on the same catheter size and balloon volume.No deflation issue was observed.Balloons are still inflated to its normal condition and shape.In our current standard operating procedure, the products are subjected to 100% visual inspection, and leak test.Any defective raw balloon will be culled out before being sent to the next process.Based on the investigation conducted, we could not link any process discrepancy that could lead to the balloon split issue.Therefore, we could not confirm the complaint, as stated.
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