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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 Break (1069); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2020
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 during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was not able to be rotated and the bands failed to deploy.It was noted that 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 okay.
 
Manufacturer Narrative
Block h6: device code 2610 for the reportable issue of bands failed to deploy.Device code 1069 for the reported issue of handle broken.Block h10: investigation results the returned speedband superview super 7 was analyzed, and a visual evaluation noted that the ligator head was not returned with the device.It was noticed that the crimp was present on the tripwire.It was also noted that the tripwire was not secured in the spool of the handle, as there were no drag marks found and the trip wire was attached to the shank welded.Some drag marks were found on the spool of the handle, indicating that the device was highly manipulated.It was possible to observe that a deformation was found at the edge of the handle bracket.Additionally, the suture remained attached to the tripwire loop and showed seven knots.Functional evaluation could not be performed due to the handle that could not be rotated.No other issues with the device were noted.The reported event was confirmed.Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label that the trip wire was not properly secured in the handle slot, as indicated in the step 8.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was not able to be rotated and the bands failed to deploy.It was noted that 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 okay.
 
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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 Key9801140
MDR Text Key190827489
Report Number3005099803-2020-00727
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 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/06/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0024551639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Date Manufacturer Received03/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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