Only the distal fragment of the instrument was returned.The returned device fragment was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned device fragment revealed that the hypotube is kinked at several locations and has fractured about 108 cm proximal to the distal end of the device.The cross-section of the hypotube is no longer circular, but compressed and the polymer coating is plastically deformed.This indicates that the hypotube most probably fractured as a result of significant bending outside the patients body.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling of the device.
|