(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The 12x60mm armada 35 referenced is being filed under a separate medwatch mfr number.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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(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 issued to the reported lot that would have contributed to this event.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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