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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL Back to Search Results
Model Number M00542250
Device Problems Break (1069); Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/18/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during an endoscopic ligature procedure to treat esophageal varices, full hemorrhage performed on (b)(6) 2022.During the procedure, during the deployment of the band after the varicose vein was suctioned, it was noticed that the band would not deploy and there was no audible click after the handle was rotated.When the handle was rotated for the second time, same problem happened.The device was removed along with the endoscope, and it was noticed that the bands did not deploy because the trip wire was broken.To stop the bleeding, the procedure was completed with another speedband superview super 7.It was noted that there was no difficulty experienced upon setting up the device.There were no reported patient complications as a result of this event.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Block h6: medical device problem code a050501 captures the reportable event of bands unable to deploy.Medical device problem code a0401 captures the reportable event of trip wire broken.Block h10: the returned speedband superview super 7 (handle and the ligator housing) was analyzed, and a visual evaluation noted that the returned ligator housing had seven bands attached and some of them were moved and overlapped, some bands were cracked/damaged, and one band was broken.The suture thread has been fully unfolded from the ligator housing and it still had the seven bands attached.The handle slot had marks of the insertion of the trip wire.The suture thread contained the seven knots.The ligator housing teeth were found bent/damaged.The suture hole and the trip wire were in good condition.A functional evaluation was performed by rotating the handle knob.It could be rotated without any problems.The click was audible, and indents felt each 180 degrees rotation.No problems with the device were noted.The reported event of bands unable to deploy was confirmed.Upon analysis, it was found that some bands attached in the ligator head were moved, overlapped, cracked, and one band was broken.The ligator housing teeth were bent/damaged.These suggest that the device was unable to deploy the bands.The reported event of broken trip wire was not confirmed as the trip wire and the suture thread were in good condition, and the handle slot had marks of insertion of the trip wire.The reported patient problem "hemorrhage, minor" was assigned as "known inherent risk of device", because it is known and documented in the labeling (including both short or long term known complications or adverse reactions).The bent teeth suggests that the excess tension applied when trying to deploy the bands could have resulted in the bands moving from their place, as if twisting them, even causing the rupture of one band.This clearly indicates inability of the device to deploy the bands.It is possible that the functionality of the device has been affected in some way; perhaps an excess of force, manipulation, the technique used, or the patient's anatomical conditions could have contributed to the reported event.Therefore, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during an endoscopic ligature procedure to treat esophageal varices, full hemorrhage performed on (b)(6) 2022.During the procedure, during the deployment of the band after the varicose vein was suctioned, it was noticed that the band would not deploy and there was no audible click after the handle was rotated.When the handle was rotated for the second time, same problem happened.The device was removed along with the endoscope, and it was noticed that the bands did not deploy because the trip wire was broken.To stop the bleeding, the procedure was completed with another speedband superview super 7.It was noted that there was no difficulty experienced upon setting up the device.There were no reported patient complications as a result of this event.
 
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Brand Name
SPEEDBAND SUPERVIEW SUPER 7
Type of Device
LIGATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15897441
MDR Text Key308073447
Report Number3005099803-2022-07101
Device Sequence Number1
Product Code MND
UDI-Device Identifier08714729201953
UDI-Public08714729201953
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
510K EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/23/2023
Device Model NumberM00542250
Device Catalogue Number4225
Device Lot Number0030005589
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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