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 01/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(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 esophagus during a varicose vein ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the suture detached and the bands would not deploy.The procedure was completed with another speedband superview super 7.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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Initial reporter facility name: (b)(6).Problem code 2610 captures the reportable issue of bands failed to deploy.Problem code 2907 captures the reportable issue of suture detached.Investigation results: a speedband superview super 7 was returned with the ligator head for analysis.It was noticed that the crimp was present on the trip wire.A visual examination of the ligator head found six bands present which indicates that the bands failed to deploy during the procedure.It was also noticed that the ligator teeth were bent.The suture was intact and was detached from the ligator head.The trip wire was partially rolled in the handle and was secured in the handle assembly slot when received.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issue was noted with the handle assembly.Based on the evaluation of the returned ligator head, 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 which could have contributed with the reported issues.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 esophagus during a varicose vein ligation procedure performed on (b)(6), 2019.According to the complainant, during the procedure, it was noted that the suture detached and the bands would not deploy.The procedure was completed with another speedband superview super 7.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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