MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Speedband Superview Super 7; Ligator, Esophageal

Model Number	M00542251
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophageal variceal ligation procedure performed on (b)(6)2026 for the treatment of esophageal varices.During the procedure, the mechanical structure of the ligation device was abnormal, and the band could not be deployed normally.The ligation operation could not be completed.There was no difficulties setting up the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a050501 captures the reportable event of bands failure to deploy.

• Brand Name: Speedband Superview Super 7
• Common Device Name: Ligator, Esophageal
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50733902
• Report Number: 3005099803-2026-03720
• Device Sequence Number: 10633568
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: (01)08714729201960(17)270204(10)38544194
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00542251
• Device Catalogue Number: M00542251
• Device Lot Number: 0038544194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 02/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 112 LB