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Model Number M00522610 |
Device Problem
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 03/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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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 stomach during a gastric endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the clip was unable to disconnect 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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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in stomach during a gastric endoscopic submucosal dissection (esd) procedure performed on march 28, 2022.During the procedure, the clip was unable to disconnect 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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Manufacturer Narrative
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Block h6: medical device problem code a15 captures the reportable event of clip unable to disconnect from the catheter.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and the device had evidence of premature deployment.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the bushing had hit marks.The yoke was returned attached to the control wire.Dimensional examination was performed on the bushing outer diameter and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip unable to disconnect from the catheter was not confirmed.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.Regarding the yoke was returned attached to the control wire, this could be due to operational factors during the procedure such as trying to open the clip once it was already activated.The device was returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take in consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components dimensions interfered with the device performance.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Search Alerts/Recalls
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