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	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a band ligation was used in an unknown location for an esophageal varices treatment via gastroscopy procedure performed on (b)(6) 2026.During the procedure the bands were stuck together, and it could not be deployed normally.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition is stable after the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a050501 captures the reportable event of bands failure to deploy.Device evaluation.The device was not returned for analysis; therefore, a technical analysis could not be performed.A device media analysis was performed.During the media inspection of the video attached it was possible to observe that the bands were not able to deploy.A device history record review was completed.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the event description, information and media provided by the customer there is not enough evidence to determine whether the issue was induced by the physician technique during the procedure or it was related to a device malfunction, " cause not established" is selected as the most probable cause for this event.All compiled information on this investigation determines that the most probable cause is "cause not established".

• 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: 50842168
• Report Number: 3005099803-2026-03884
• Device Sequence Number: 16019879
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• 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): 09/21/2026

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: 0038774646
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• 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 Sex: Unknown