The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).The risk of the reported event has been addressed in the risk documentation and there are current controls in place to mitigate the risk of the as reported event.Based on the information currently available, it is probable the tortuosity of the patients anatomy may have caused difficulties during the procedure, therefore an assignable cause of procedural factors will be assigned to the investigation.
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