Date of event was approximated to be (b)(6) 2018 as no event date was reported.(b)(4).A visual assessment was performed after disinfection.As received, the working channel sleeve (wcs) protruded.Maximum wcs protrusion remained consistent when the distal tip was articulated by turning the knobs in all directions.An image assessment for visualization was performed.Upon plugging the device into the controller, it displayed a live, clear image.No issues were identified with the image.The device was fully articulated in all directions; no issues were identified with the image.A guidewire and a spybite were inserted separately through the working channel port and passed through the working channel; no issues were identified with the image.The handle was opened and it was found within specification.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white and clear areas along bond a, as well as the proximal strands remaining attached to the pebax, appear to show evidence of adhesion.It was found during the investigation of the returned spyscope ds that the working channel sleeve was protruding.Based on investigation results, the underlying cause of working channel sleeve protrusion is an insufficient bond, particularly the second heat cycle of the working channel sleeve bonding process [bond b].Working channel sleeve protrusion in devices manufactured post 01mar2018 changes has been determined to be a design issue, therefore, the complaint investigation conclusion code selected for the working channel sleeve protrusion issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation is underway to address this issue.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was returned as it was defective.According to the complainant, the device was returned as it was thought to be defective.There were no reported patient complications as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.This event has been deemed a reportable event based on the investigation results; working channel sleeve protrusion.
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