(b)(4).Date of event - estimated.Evaluation summary: the device was returned for evaluation.There was balloon material shredding on the proximal balloon taper.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.In this case, it is likely the device interacted with the anatomy/mildly calcified lesion during advancement and therefore was unable to cross.Additionally, this interaction likely resulted in the noted balloon material shredding.Based on visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.
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