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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL
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BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL Back to Search Results
Model Number M00542251
Device Problem Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the gastrointestinal (gi) during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands did not deploy.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 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.
 
Manufacturer Narrative
Block h6: device code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results the returned speedband superview super 7 device and the ligator head were analyzed.A visual evaluation noted that the tripwire was mechanically cut and was outside of the handle and it was noticed that the proximal loop was not returned.The handle assembly slot where the tripwire was inserted and secured showed drag marks, indicating that the device was used.It was noted that the distal loop was attached to the suture and was connected to the ligator head.It was possible to observe that the ligator head found six bands attached; however, five bands were moved out of their original positions and one band was not returned.It was noted that some of the ligator head teeth were bent.Additionally, the suture hole was in good condition and no damages were observed.A functional evaluation was not performed due to the tripwire was cut.No visible issue was noted with the handle assembly.No other issues with the device were noted.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 generated the bands to moved out of their original positions, impacting the bands deployment activity and could have contributed to the reported issues.There was evidence that the trip wire was cut in order to remove the device from the scope.This condition is not considered as an issue of the device.The reported event was confirmed.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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the gastrointestinal (gi) during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands did not deploy.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 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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Brand Name
SPEEDBAND SUPERVIEW SUPER 7
Type of Device
LIGATOR, HEMORRHOIDAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9588698
MDR Text Key189906037
Report Number3005099803-2019-06486
Device Sequence Number1
Product Code FHN
UDI-Device Identifier08714729201960
UDI-Public08714729201960
Combination Product (y/n)N
PMA/PMN Number
510K EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/16/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023963731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Date Manufacturer Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age46 YR
Patient Weight85
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