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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 Problems Positioning Failure (1158); Use of Device Problem (1670); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2019
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 two speedband superview super 7 devices were used in the esophagus during a band ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, resistance was felt and the bands failed to deploy.The same issue occurred with second speedband superview super 7 device and the procedure was completed with a different device.Additionally, it was noted that there was no difficulty when setting up the 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 okay.
 
Event Description
It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during a band ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, resistance was felt and the bands failed to deploy.The same issue occurred with second speedband superview super 7 device and the procedure was completed with a different device.Additionally, it was noted that there was no difficulty when setting up the 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 okay.
 
Manufacturer Narrative
Block h6: problem code 2610 captures the reportable issue of bands failed to deploy.Block h10: investigation result: received one speedband superview super 7 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 four bands present.It was noticed that the ligator teeth were bent.The suture was noted to be intact and attached to the trip wire loop and ligator head.The trip wire was cut with a sharp tool, the cut ends were inspected in magnified visual system.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No 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.Also the trip wire appears to had been cut with a sharp tool and this condition is not considered as an issue of the device.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.
 
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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 Key8603268
MDR Text Key144829230
Report Number3005099803-2019-02469
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 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2018
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0021395018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Date Manufacturer Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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