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

Model Number	M00505430
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6 imdrf code f1001 is being used to capture the reportable event of procedure cancelled/rescheduled - post sedation/sedation unknown.Device evaluation: block h11: the overstitch nxt was not returned for evaluation as it was disposed; however, media was provided for analysis.The documentation included a picture where it can be observed a screen when it is possible to identify the cap of the overstitch.However, it is not possible identify any issues.The reported event of cap damaged could not be confirmed.A risk review of the overstitch nxt was completed and confirmed that the event of cap damaged/defective and cancelled/rescheduled post sedation/sedation unknown was defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence the device was improperly used per the instructions for use (ifu), and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Based on all gathered information, there is not enough evidence to determine whether the cap damaged/defective was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, cause not established is selected as the most probable cause for this event.Additionally, for the event cancelled/rescheduled post sedation/sedation unknown, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.For this reason, will be classified as cause not established.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026.After setting up the device, the endcap rotated.As a result, the alignment tube was out of sight, and the view of the needle driver was partially obstructed.The procedure was cancelled after the patient was under sedation.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH NXT ENDOSCOPIC SUTURING 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: 25247447
• Report Number: 3005099803-2026-02015
• Device Sequence Number: 10547655
• Product Code: OCW
• UDI-Device Identifier: 00191506060107
• UDI-Public: (01)00191506060107
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 05/21/2026

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: M00505430
• Device Catalogue Number: M00505430
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/21/2026
• 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