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Model Number M00522600 |
Device Problems
Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Imdrf device code a15 captures the reportable event of clip could not be deployed.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.It was reported that the device was removed, and the procedure was completed with another resolution clip.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the instructions for use, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.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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Manufacturer Narrative
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Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the clip assembly bottom part was deformed.Functional evaluation was performed, and it was found that the handle does not have communication with the clip assembly.No other problems with the device were noted.The reported event of clip could not be deployed was confirmed.It is possible that the amount of tissue grasped was bigger than the clip could close, causing the customer needed to apply an excessive force to close the clip arms in order to activate them.However, due to the amount of tissue grasped, this force was enough to detach the clip from the bushing, but it was not enough to activate them.Subsequently, due to this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned.Additionally, it is most likely that the physician kept pulling back the clip which cause the control wire and clip detachment, causing a deployment problem.Regarding the found problem of clip assembly deformed, this is likely due to the entrapment against the bushing.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as it was reported that the over-sheath was attempted to be completely removed from the device which is not describe in the instructions for use.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.It was reported that the device was removed, and the procedure was completed with another resolution clip.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the instructions for use, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.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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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.It was reported that the device was removed, and the procedure was completed with another resolution clip.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the instructions for use, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.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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Manufacturer Narrative
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Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the clip assembly bottom part was deformed.Functional evaluation was performed, and it was found that the handle does not have communication with the clip assembly.No other problems with the device were noted.The reported event of clip could not be deployed was confirmed.It is possible that the amount of tissue grasped was bigger than the clip could close, causing the customer needed to apply an excessive force to close the clip arms in order to activate them.However, due to the amount of tissue grasped, this force was enough to detach the clip from the bushing, but it was not enough to activate them.Subsequently, due to this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned.Additionally, it is most likely that the physician kept pulling back the clip which cause the control wire and clip detachment, causing a deployment problem.Regarding the found problem of clip assembly deformed, this is likely due to the entrapment against the bushing.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as it was reported that the over-sheath was attempted to be completely removed from the device which is not describe in the instructions for use.
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Search Alerts/Recalls
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