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Model Number M00542251 |
Device Problems
Failure to Fire (2610); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/29/2019 |
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 speedband superview super 7 device was used in the fundus of the stomach during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands would not release and the suture detached from the device.The procedure was completed with another seedband superview super 7 device.Additionally, there was no difficulty in setting up the device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: problem code 2610 captures the reportable issue of bands failed to deploy.Problem code 2907 captures the reportable issue of suture detached.Block h10: investigation results received one speedband superview super 7 with the ligator head for analysis.It was noticed that the crimp was present on the trip wire and the trip wire was secured in the handle assembly slot when received.A visual examination of the ligator head found seven bands present which were moved out of their original positions with one band was caught under other bands.It was also noticed that the ligator teeth were bent.Also, the suture was found broken in the loop section and was attached to the ligator head.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issue noted with the handle assembly.Based on the evaluation of the returned complaint device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during the procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have impacted the bands deployment activity, moving bands without being deployed, and contributing to the reported issues.Also, the suture can tangle with the bands which can result in difficulty to rotate the handle and continued attempts to deploy the bands can result in suture breakage.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 speedband superview super 7 device was used in the fundus of the stomach during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands would not release and the suture detached from the device.The procedure was completed with another seedband superview super 7 device.Additionally, there was no difficulty in setting up the device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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