(b)(4).A wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection was performed and found one section of the inner sheath was detached from the outer sheath.The stainless steel (handle) was broken, the outer blue sheath was detached from the handle (handle break) and the outer sheath was accordioned.Functional examination could not be performed due to the condition of the returned device.No other problems were noted to the stent and delivery system.Based on the available information, the investigation concluded that the observed failures were most likely due to procedural factors encountered during the procedure.It may be that the characteristics of the lesion, handling and manipulation of the device, the techniques used by the user, and/or normal procedural difficulties encountered during the procedure limited the performance of the device.Therefore, contributing to inner sheath detachment.This type of damage could result to stent unable to be deployed.The reported event of device difficult to advance guidewire could not be confirmed.There was no confirmation on what the customer indicated due to the condition of the returned device.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
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