Model Number M00521231 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2018 |
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 failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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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 during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the clip was attempted to be deployed; however, the clip failed to release from the catheter even after multiple techniques of opening and closing the handle.Reportedly, the catheter with the clip was then pulled off from the tissue.It was noted that the clip appeared to be damaged, hanging on only by the control wire.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Problem code 2906 captures the reportable event of clip failed to release from the catheter.A visual examination of the returned complaint device noted that the catheter was severely kinked in the distal end and in the middle section.The tabs were locked into the capsule and the prongs were not aligned.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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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 during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the clip was attempted to be deployed; however, the clip failed to release from the catheter even after multiple techniques of opening and closing the handle.Reportedly, the catheter with the clip was then pulled off from the tissue.It was noted that the clip appeared to be damaged, hanging on only by the control wire.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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