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 05/07/2022 |
Event Type
malfunction
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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 intestinal tract during a painless gastroenterostomy procedure performed on (b)(6) 2022.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.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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(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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Manufacturer Narrative
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Block h6: medical device problem code a15 captures the reportable event of clip unable to release from the catheter.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 attached.The device was returned without the over-sheath.Microscopic examination was performed and it was found that the coil was unraveled next to the bushing.Functional evaluation was performed, and it was observed that the device can open its arms within specification under the tortuous path.Additionally, the clip assembly was able to perform the first activation and could be released from the catheter without problem.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.It is possible that the removal of the over-sheath or the interaction between the device with the scope during the insertion of the device could have lead to the found problem of catheter unraveled.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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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during a painless gastroenterostomy procedure performed on (b)(6) 2022.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.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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Search Alerts/Recalls
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