MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OverStitch Suture Cinch; Endoscopic Tissue Approximation Device

Model Number	M00505530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed and the product investigation revealed that the cinch wire was broken and the cinch failed to deploy.See block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: as no event date was provided, the date the device was returned to boston scientific (02 july 2026) is being used as the estimated event date.Block h6: imdrf device code a0401 captures the reportable event of cinch wire break.Imdrf device code a150101 captures the reportable event of cinch failure to deploy.Block h11: device evaluation.The returned suturing cinch was analyzed.A visual inspection was performed.The unit returned with the partial detachment in the handle to manually fire cinch and without the plug and collar.In a microscopic inspection, it was identified the plunger slightly rotated in housing.Additionally, it was necessary to separate the hypotube from the handle to identify the crimp and screw marks in the hypotube and finally, beaded wire was found returned inside this component.It was necessary to kink the working length to identify the lumen inside, and lumen was found.The product investigation found the catheter damaged, cinch wire broken, and the handle damaged.It was confirmed during the dhr review that there were no manufacturing deviations which could have contributed to the reported event.However, based on further investigation, a relationship was identified between the manufacturing process and the failure mode.Based on all gathered information, most likely procedural factors such as the handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.The device failed to deploy during the procedure, which required the use of pliers to manually actuate the mechanism and enable device removal this is confirmed with the product condition returned.This sequence of events indicates that an initial functional failure of the cutting mechanism must have occurred prior to the manual intervention.The device analysis revealed internal mechanical damage, including a partial detached in the handle, beaded wire break and component misalignment, which is consistent with a compromised actuation system.While part of the observed damage may have been related to the use of an additional tool, these findings are consistent with the reported functional failure.Therefore, the manufacturing process presents a relationship with this failure mode, and the investigation will be closed as a manufacturing deficiency.

• Brand Name: OverStitch Suture Cinch
• 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 ; +1(914)571-6918
• MDR Report Key: 50193792
• Report Number: 3005099803-2026-03243
• Device Sequence Number: 14976886
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046(17)280723(10)37049911
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: M00505530
• Device Catalogue Number: M00505530
• Device Lot Number: 0037049911
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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