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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 02/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Facility address: (b)(6).(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 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 condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block e1: facility address: (b)(6).Block h6: medical device 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 and the over-sheath was not returned with the device.Microscopic examination was performed and it was found that the clip assembly had both activations performed as the locking tabs of the clip were opened.Additionally, there was no evidence of flaring found on the capsule.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 device was returned with the clip assembly attached and with both activations performed which is an evidence that the clip was able to 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 february 16, 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 condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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