MAUDE Adverse Event Report: ASSUT EUROPE SPA OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	PLY-G02-020-A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a gastric fistula repair procedure performed on (b)(6) 2024.During the procedure, the overstitch nxt is assembled as shown in the training.After making the first stitch in the gastric mucosa, an attempt is made to make a second stitch, but the space is very small and almost prevents the movement and vision of the endoscope.After several attempts to adjust the position (moving the endoscope) to be able to work and especially to have vision, we see the dark part of the endcap on the screen and understand that that part has been welded/loosened.After releasing the needle and closing the system to be able to exit with maximum safety, the needle remains trapped in the system, causing a new complication.Finally, the thread-needle union breaks, and we can leave, verifying that, indeed, the final part has completely come out of the endoscope.The procedure was completed with a fully covered esophageal prosthesis due to the laceration produced and subsequent bleeding.Patient fully recovered from the event and another surgery has been scheduled.
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Device evaluation: the overstitch suture was not returned for analysis however, media inspection performed to the photos provided as complaint attachments shows the suture ruptured from the needle.Therefore, the allegation is confirmed.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a gastric fistula repair procedure performed on (b)(6) 2024.During the procedure, the overstitch nxt is assembled as shown in the training.After making the first stitch in the gastric mucosa, an attempt is made to make a second stitch, but the space is very small and almost prevents the movement and vision of the endoscope.After several attempts to adjust the position (moving the endoscope) to be able to work and especially to have vision, we see the dark part of the endcap on the screen and understand that that part has been welded/loosened.After releasing the needle and closing the system to be able to exit with maximum safety, the needle remains trapped in the system, causing a new complication.Finally, the thread-needle union breaks, and we can leave, verifying that, indeed, the final part has completely come out of the endoscope.The procedure was completed with a fully covered esophageal prosthesis due to the laceration produced and subsequent bleeding.Patient fully recovered from the event and another surgery has been scheduled.

• Brand Name: OVERSTITCH 2-0 POLYPROPYLENE SUTURE
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ASSUT EUROPE SPA; zona industriale; magliano dei marsi 67062 ; IT 67062
• Manufacturer (Section G): ASSUT EUROPE SPA; via giuseppe gregoraci 12; rome, rm 00137
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21001553
• Report Number: 3005099803-2024-06522
• Device Sequence Number: 15155888
• Product Code: OCW
• UDI-Device Identifier: 18033439178889
• UDI-Public: 18033439178889
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: PLY-G02-020-A
• Device Lot Number: 22SE8532
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/06/2025
• Date Device Manufactured: 10/30/2022
• 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