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	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a band ligation was used in the esophagus during a endoscopic variceal ligation procedure performed on (b)(6) 2026.During the procedure, the super 7 bands were entangled and failed to deploy.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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: 50733979
• Report Number: 3005099803-2026-03721
• Device Sequence Number: 16087709
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: (01)08714729201960(17)270303(10)38787817
• 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: 0038787817
• 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: 03/03/2026
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 140 LB