The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the coil was jammed inside the microcatheter.In addition, the ptfe (polytetrafluoroethylene) was visible from the distal end of the catheter.It is most probable that procedural or anatomical factors encountered during the procedure contributed to the reported event resulting in excessive force used which would have resulted in the ptfe inner lining peeling.An assignable cause of ¿cause traced to component failure¿ will be assigned to the reported and analyzed event as the issue is associated with a product that meets the design and manufacture specifications and was used in accordance with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.
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