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

Model Number	M00505550
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of handle break.Imdrf code a150101 captures the reportable event of failure to deploy.Imdrf code f2301 captures the reportable event of additional device required to manually deploy the cinch.
Event or Problem Description
It was reported to boston scientific corporation that a suturing cinch was used in an endoscopic submucosal dissection (esd) procedure on (b)(6) 2026, for the treatment of a colonic mass.During the procedure, the suturing cinch handle snapped upon deployment and the cinch would not deploy.Troubleshooting attempts were made including trying to open the handle and jiggle it.The physician had to cut the wire and manually deploy the cinch.The procedure was completed with another of the same device.No patient complications were reported as a result of the event.
Event or Problem Description
It was reported to boston scientific corporation that a suturing cinch was used in an endoscopic submucosal dissection (esd) procedure on (b)(6) 2026, for the treatment of a colonic mass.\ \ during the procedure, the suturing cinch handle snapped upon deployment and the cinch would not deploy.Troubleshooting attempts were made including trying to open the handle and jiggle it.The physician had to cut the manually cut the suture and remove the suture cinch.\ \ the procedure was completed with another of the same device.\ \ no patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6:\ imdrf code a0401 captures the reportable event of handle break\ imdrf code a150101 captures the reportable event of failure to deploy\ imdrf code f2301 captures the reportable event of additional device required\ \ correction: \ correction to b5: describe event or problem \ \ investigation summary\ the suture cinch was returned with the handle detached and without the peek plug and collar and without the beaded wire.In a microscopic inspection, it was observed that the plunger slightly rotated in housing.\ \ 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 and handle break were 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.\ \ in regard to \"catheter damaged, cinch wire break and handle break\", these reported events are most likely a procedural factor as handling of the device and the technique used by the physician (force applied) and could have resulted in damage 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.\ \ based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of \" manufacturing deficiency\".
Additional Manufacturer Narrative
Block h6:\ imdrf code a0401 captures the reportable event of handle break.\ imdrf code a150101 captures the reportable event of failure to deploy.\ imdrf code f2301 captures the reportable event of additional device required.\ \ correction: \ correction to b5: describe event or problem.\ \ investigation summary\ the suture cinch was returned with the handle detached and without the peek plug and collar and without the beaded wire.In a microscopic inspection, it was observed that the plunger slightly rotated in housing.\ \ 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 and handle break were 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.\ \ in regard to \"catheter damaged, cinch wire break and handle break\", these reported events are most likely a procedural factor as handling of the device and the technique used by the physician (force applied) and could have resulted in damage 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.\ \ based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of \" manufacturing deficiency\".\ \ in july 2026, boston scientific initiated a voluntary product removal associated with specific lots of the overstitch suture cinch (ref.97622075).The referenced device was in scope of this product removal.
Event or Problem Description
It was reported to boston scientific corporation that a suturing cinch was used in an endoscopic submucosal dissection (esd) procedure on 1 may 2026, for the treatment of a colonic mass.\ \ during the procedure, the suturing cinch handle snapped upon deployment and the cinch would not deploy.Troubleshooting attempts were made including trying to open the handle and jiggle it.The physician had to cut the suture and remove the suture cinch.\ \ the procedure was completed with another of the same device.\ \ no patient complications were reported as a result of the event.

• Brand Name: Suture Cinch - Long
• 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: 25321770
• Report Number: 3005099803-2026-02178
• Device Sequence Number: 5368796
• Product Code: OCW
• UDI-Device Identifier: 00191506049188
• UDI-Public: (01)00191506049188(17)280720(10)37019759
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: M00505550
• Device Catalogue Number: M00505550
• Device Lot Number: 0037019759
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2026
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 06/19/2026; 07/14/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/16/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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
• 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