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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of break.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2024 that an overstitch endoscopic suture system that two sutures went wrong during the course of the procedure.During the procedure, when preforming the second suture, the first suture broke as the thread came out of the anchor.The procedure was completed with another suture, and there was no patient complication reported as a result of this event.

• 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 00137 ; IT 00137
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19040030
• Report Number: 3005099803-2024-01447
• Device Sequence Number: 20638788
• Product Code: OCW
• UDI-Device Identifier: 18033439178889
• UDI-Public: 18033439178889
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/04/2024

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: 22SE7056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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