(b)(4) captures the reportable event of clip was unable to release from catheter.(b)(4).The complainant indicated that the device has been disposed and is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that three resolution 360 clip devices were used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, first clip locked onto tissue and successfully released and deployed onto tissue.However, the three subsequent clips had difficulty getting down the olympus colonoscope.Additionally, the clips grasped and locked onto tissue, but were unable to release from the catheter to deploy.In the stages of deployment, snap and crackle were felt but there was no pop.The procedure was completed with another resolution 360 clip device.There were no patient complications have been reported due to this event.
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