(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation and the reported balloon rupture was confirmed.Based on visual and scanning electron microscopy imaging analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported balloon rupture appears to be due to operational context.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted that the armada 35 instruction for use instructs to prepare the device prior to insertion into the patient.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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