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 01/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, 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 the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, 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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Block e1: initial reporter address: (b)(6) block h6: medical device problem code a15 for the reportable event of clip unable to release from the catheter.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.Block h11: correction: block b3 (date of event) and block b5 (describe event or problem).
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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 colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, 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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Block e1: initial reporter address: (b)(6).Block h6: medical device problem code a15 for the reportable event of clip unable to release from the catheter.Block h10: investigation results: was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached and with evidence of full deployment.The clip assembly was returned in a separate bag.Additionally, the over-sheath was not returned with the device.Microscopic examination was performed and it was found that the clip assembly had evidence of proper deployment as both activations were performed.No problems were observed on the bushing.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the clip assembly was returned in a separate bag and with both activations performed which is an evidence that the clip did deploy.However, there is not enough information, objective evidence, or descriptive conditions to understand what could have caused the reported event.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 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 colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, 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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