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

Model Number	M00505530
Medical Device Problem Codes	Failure to Cut (2587); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that an overstitch suture cinch was used in a procedure performed on (b)(6) 2026.During the procedure, the device exhibited a condition where the cinch was being deployed, and it did not release from tissue.The physician attempted to "crunch" the handle, but the wire mechanism was bent within the handle.The cinch should have severed the suture and released from tissue.The procedure was completed after an extended time with another product of the same model.The patient outcome following the procedure is currently unknown, and there was no report about patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific that an overstitch suture cinch was used in a procedure performed on (b)(6) 2026.During the procedure, the device exhibited a condition where the cinch was being deployed, and it did not release from tissue.The physician attempted to "crunch" the handle, but the wire mechanism was bent within the handle.The cinch should have severed the suture and released from tissue.The procedure was completed after an extended time with another product of the same model.The patient outcome following the procedure is currently unknown, and there was no report about patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a050702 is being used to capture the reportable event of cinch failure to cut.Device code a150101 is being used to capture the reportable event of cinch failure to deploy.Imdrf code f2301 is being used to capture the reportable event of additional device required.In july 2026, boston scientific initiated a voluntary product removal associated with specific lots of the overstitch suture cinch (ref.(b)(4)).The referenced device was in scope of this product removal.Block h11: device evaluation the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, device availability information was not available per the account.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Additional Manufacturer Narrative
Block h6: device code a050702 is being used to capture the reportable event of cinch failure to cut.Device code a150101 is being used to capture the reportable event of cinch failure to deploy.Imdrf code f2301 is being used to capture the reportable event of additional device required.In july 2026, boston scientific initiated a voluntary product removal associated with specific lots of the overstitch suture cinch (ref.(b)(4)).The referenced device was in scope of this product removal.

• 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: 50061121
• Report Number: 3005099803-2026-03069
• Device Sequence Number: 13098704
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046(17)290325(10)38939941
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00505530
• Device Catalogue Number: M00505530
• Device Lot Number: 0038939941
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 03/26/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-07142026-006R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female