MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number	M0068507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Dyspareunia (4505)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the implantation of a new solyx sling, an eroded tape was observed in the patient's urethra.During a routine follow-up, the patient presented with dyspareunia, a urinary tract infection, and mesh at the urethral lumen.The patient also experienced discomfort and pain.Consequently, the entire sling, including the mesh carriers, was removed, and the holes in the urethra were repaired.
Additional Manufacturer Narrative
Block h6: patient code e2006 captures the reportable event of mesh that eroded into the urethra.Patient code e1405 captures the reportable event of dyspareunia.Patient code e1310 captures the reportable event of urinary tract infection.Patient code e2330 captures the reportable event of pain.Impact code f1903 captures the reportable event of entire sling removal.

• Brand Name: SOLYX SIS SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 21774818
• Report Number: 2124215-2025-20881
• Device Sequence Number: 15472130
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044(17)260708(10)31975718
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 07/08/2026
• Device Model Number: M0068507000
• Device Catalogue Number: M0068507000
• Device Lot Number: 0031975718
• 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: 03/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 07/09/2023
• 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 Age: 49 YR
• Patient Sex: Female