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

Model Number	M0068507010
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040609 captures the reportable code of delivery device tip bent.Block h11: upon receipt at our quality assurance laboratory, this solyx device underwent a thorough analysis.Visual inspection of the device reveals that one of the mesh carriers was detached and the delivery device tip was bent.During functional test, the delivery device appeared to have been used.However, the mechanism doesn't operate due to needle being bent.Based on the information available and analysis results, the reported allegation of mesh carrier detachment and delivery device tip bent is confirmed through product analysis.A conclusion code of adverse event related to procedure was assigned to this investigation since it is likely that procedural conditions, such as user handling technique during placement or advancement of the mesh, resulted in mesh carrier detaching and the additional observation of delivery device tip bent.
Event or Problem Description
It was reported that during a procedure using a solyx blue sis system device, the mesh detached from the anchor in the sling.The procedure was completed using advantage fit blue device.There were no patient complications reported.This event has been deemed reportable based on the investigation finding that the delivery device tip was bent.

• Brand Name: SOLYX BLUE
• 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: 24415734
• Report Number: 2124215-2026-09845
• Device Sequence Number: 10527124
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)281012(10)37687053
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/23/2026

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: M0068507010
• Device Catalogue Number: M0068507010
• Device Lot Number: 0037687053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Female