The returned instrument 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 revealed that the hypotube has fractured about 20 cm distal to the distal end of the kink protector.Kinks were observed close to the fracture sites of both fragments.The cross-sections of the hypotube are no longer circular, but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of 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.It should be noted that the ifu advises the user to not force the passage if any resistance is felt, and that the procedure should be aborted if the stent system is unable to reach or cross the lesion easily.
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