Device evaluated by manufacturer: returned product consisted of an isleeve introducer sheath with the dilator inside the sheath.The device was bloody.Analysis of the tip, sheath, and hub/valve included microscopic and visual inspection.Inspection revealed numerous kinks in the sheath and tip damage (torn).The seams of the device were opened, consistent with device used.Functional testing could not be performed due to the excessive sheath damage (kinking).Procedural imaging was provided to assist in the investigation and was reviewed by a boston scientific quality engineer.A single, 25-second-long movie file was provided for review.The file shows the withdrawal of the lotus edge device through the isleeve without issue post valve release.The complaint event of difficulty advancing the lotus edge device into the introducer sheath cannot be confirmed from this file.
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