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	09/04/2026
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 during a procedure performed on (b)(6) 2026.During the procedure, one band was successfully deployed but after that no additional bands could be deployed.It appeared as one band shifted over the remaining bands preventing deployment.No additional information was provided regarding how the procedure was completed.No information regarding patient outcome was provided.
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: 50934677
• Report Number: 3005099803-2026-03956
• Device Sequence Number: 18516223
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 0039006919
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 03/29/2026
• 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 Sex: Unknown