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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 Failure to Fire (2610); Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band was successfully deployed; however, the band failed to remain attached to the varix and several bands would not release.The same issue occurred with the second speedband superview super 7 device, and the procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band was successfully deployed; however, the band failed to remain attached to the varix and several bands would not release.The same issue occurred with the second speedband superview super 7 device, and the procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Problem code 2949 for the reportable issue of bands falling of varix.Block h10: investigation results a speedband superview super 7 was returned with the ligator head and suture for analysis.A visual examination of the ligator head found three bands present which were moved out of its original position.It was also noticed that the ligator teeth were bent.No other issue was noted.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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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 Key8586330
MDR Text Key144277320
Report Number3005099803-2019-02356
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 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/23/2019
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0022831035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2019
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age37 YR
Patient Weight65
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