Model Number M00521232 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
Tissue Damage (2104)
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Event Date 02/17/2020 |
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 was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip grasped and locked onto tissue, but failed to release from the catheter to deploy.Reportedly, when the clip was removed from the patient it pulled off some tissue, which increased the size of the polypectomy lesion.The procedure was completed with another resolution 360 clip device.The patient 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 360 clip was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip grasped and locked onto tissue, but failed to release from the catheter to deploy.Reportedly, when the clip was removed from the patient it pulled off some tissue, which increased the size of the polypectomy lesion.The procedure was completed with another resolution 360 clip device.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 h6: device code 2906 captures the reportable event of clip failed to release from the catheter.Block h10: investigation results: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the clip assembly was returned attached to the device.Microscope examination was performed on the clip assembly, and it was noted under high magnification that activations had been performed.It was also noted that the capsule locking tabs appeared damaged and the bushing had some marks in its hooks.Functional evaluation was performed using a tortuous path and the clip released from the catheter successfully.Dimensional examination was performed to further analyze the deployment issue; the handle was disassembled, and it was confirmed that the flattening wire was within specification.It was also noted that the control wire had some kinks.A dimensional examination was performed on the braided shaft, and it was within specification.No other issues with the device were noted.The reported event was confirmed.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.An investigation is in place to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
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Search Alerts/Recalls
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