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

Model Number	M00505530
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a suturing cinch was utilized during a procedure on (b)(6) 2026.During the procedure, the suturing cinch failed to deploy as intended.The cinch was manually deployed.During the manual deployment process, the technician sustained a small cut to their hand that required only a band aid and no further medical intervention.The procedure was completed successfully using the original device.No patient complications were reported due to the event.
Additional Manufacturer Narrative
Block h6: 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.
Event or Problem Description
It was reported to boston scientific corporation that a suturing cinch was utilized during a procedure on (b)(6) 2026.During the procedure, the suturing cinch failed to deploy as intended.The cinch was manually deployed.During the manual deployment process, the technician sustained a small cut to their hand that required only a band aid and no further medical intervention.The procedure was completed successfully using the original device.No patient complications were reported due to the event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Good faith efforts were completed to obtain this information; however further information has not been received to date.If additional details become available, a supplemental report will be submitted.Block h6: 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.Investigation results summary: the suture cinch was returned with handle detached to manually fire cinch, without the peek plug and collar and without the beaded wire.In a microscopic inspection, it was observed that the plunger was slightly rotated in the housing and the lumen into the coil.The device analysis revealed internal mechanical damage, including a detached 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.The reported events of "cinch failure to deploy was confirmed.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.Review of the instructions for use (ifu) confirmed that there was no evidence that the device was improperly used and there was sufficient guidance with respect to the circumstances described within this complaint.The reported event of needle stick/puncture is an anticipated event in the ifu.No updates are required to the ifu as a result of this event.In regard to the events of "catheter damaged, cinch wire break and handle break" the most probable conclusion was most likely procedural factors as handling of the device and the technique used by the physician (force applied) which could have resulted in the damages encountered in the device.The reported event of "additional device required" occurred during the procedure and the most probable cause of this reported issue cannot be established due to lack of evidence.According to the physician's report, the device failed to deploy during the procedure, which required the use of pliers to manually actuate the mechanism and enable device removal.This sequence of events indicates that an initial functional failure of the cutting mechanism must have occurred prior to the manual intervention.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "manufacturing deficiency".In (b)(6) 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.The batch information for the device was unable to be obtained, and boston scientific cannot confirm if the device used was within scope of the manufacturing range of the recall; however, it is being listed conservatively.

• 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: 25332563
• Report Number: 3005099803-2026-02195
• Device Sequence Number: 9861031
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00505530
• Device Catalogue Number: M00505530
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/19/2026; 07/14/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/16/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown