(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample appeared to be in a good condition except that the balloon was split.Closer examination on the split balloon area under dino-lite revealed scratch marks near the tear region.In our standard operating procedure, the raw balloons are subjected to 100% visual inspection using magnification lens.Defective raw balloon will be culled out before sent to the next process.After assembly, all foley catheters are then subjected to leak test.Product that passed this test will be subjected to the next process.Based on the investigation conducted on the actual sample, it is believed that the scratch marks found near the split area had initiated the tear.Therefore, we could not confirm this complaint as stated.
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