MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OVERSTITCH ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	M00505410
Medical Device Problem Codes	Failure to Align (2522); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code a040609 is being used to capture the reportable event of needle shaft bent.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used in the esophagus during a stent fixation procedure on (b)(6) 2026.During the procedure, the needle shaft was bent and would not align with the anchor.The anchor exchange failed to load the anchor onto the needle body.They physician tried to use a new suture but was still unsuccessful with loading the anchor.The procedure was completed with a new overstitch handle.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• 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 ; 9145716918
• MDR Report Key: 24899163
• Report Number: 3005099803-2026-01385
• Device Sequence Number: 8640576
• Product Code: OCW
• UDI-Device Identifier: 00191506060091
• UDI-Public: (01)00191506060091
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: M00505410
• Device Catalogue Number: M00505410
• Device Lot Number: 0038528622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• 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