Model Number M00521232 |
Device Problems
Unraveled Material (1664); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a gastroscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.Another attempt was made to deploy the clip but still unsuccessful.The procedure was completed with another resolution 360 clip.It was reported that the catheter was unraveled next to the bushing.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Imdrf device code a15 captures the reportable event of would not release from the catheter.
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Event Description
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It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a gastroscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.Another attempt was made to deploy the clip but still unsuccessful.The procedure was completed with another resolution 360 clip.It was reported that the catheter was unraveled next to the bushing.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a15 captures the reportable event of would not release from the catheter.Block h10: investigation results: the returned resolution 360 clip was analyzed, and a visual evaluation noted that the device was returned with the catheter cut at the middle of it.Microscopic examination was performed, and it was found that the cut section has evidence of a mechanical cut.No other problems with the device were noted.The reported event of clip could not detach from catheter was not confirmed.Investigation found that the device returned without the clip assembly section and with the catheter cut and with evidence of a mechanical cut.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
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Search Alerts/Recalls
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