(b)(4).The clip delivery system device is being filed under separate medwatch reports.Evaluation summary: the steerable guiding catheter (sgc) was returned and the reported sgc torn soft tip was confirmed.A review of the lot history record revealed no manufacturing nonconformities in this lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported clip getting caught on the guide tip, resulting in the identified tears in the soft tip appears to be related to user technique during positioning and straddling.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.
|