It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Block h6: medical device code a15 captures the reportable event of clip could not detach from catheter.Block h10: investigation analysis: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached.The clip assembly was returned in a separate bag.Microscopic examination was performed, and it was found that the clip arms were not activated; however, the locking tabs were opened, which is evidence of a proper deployment.The yoke was returned inside the clip assembly.Additionally, the bushing had hit marks on both hooks.No other problems with the device were noted.The reported event of clip could not detach from catheter was not confirmed as the clip assembly was returned properly deployed from the delivery system.Investigation found that the bushing had hit marks, this is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.However, the returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.
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