MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068502110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Pain (1994); Urinary Tract Infection (2120); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of january 30, 2018, was chosen as a best estimate based on the date the device was implanted.Block e1: this event was reported by the patient's legal representation.Block h6: the imdrf patient codes capture the reportable events of: e1405: captures the reportable event of dyspareunia.E2330: captures the reportable event of vaginal pain.E2006: captures the reportable event of mesh extrusion.E2314: captures the reportable event of urethral cutaneous fistula.E1310: captures the reportable event of recurrent urinary tract infections.E2401: captures the reportable event of chronic mesh-related issues.The imdrf impact code capture the reportable event of: f1901: captures the reportable event of multiple surgical attempts to remove the mesh.
Event or Problem Description
It was reported that an advantage fit system device was implanted in a patient during a procedure.Since then, the patient has experienced multiple complications, including dyspareunia, vaginal pain, mesh erosion through the vaginal wall, a urethral cutaneous fistula requiring reconstruction, recurrent urinary tract infections, worsening urinary incontinence, and chronic mesh-related issues necessitating multiple surgical attempts to remove the mesh.

• Brand Name: ADVANTAGE FIT SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23293127
• Report Number: 2124215-2025-72968
• Device Sequence Number: 21313888
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: (01)08714729772880(17)201009(10)21239880
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 0021239880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 10/10/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female