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	Positioning Failure (1158); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a150201 captures the reportable event of mesh difficult to position.Patient code e2330 captures the reportable event of pain felt by the patient following the procedure.
Event or Problem Description
It was reported that, during a mid-urethral sling procedure using a solyx blue device, placement of the device on the patient's right side was completed without issue, but the physician encountered difficulty with the patient's anatomy while attempting left-sided placement, resulting in contact between the trocar tip and the pelvic bone rather than advancement through the obturator muscle.Continued pressure against the bone caused the needle tip to bend.The trocar was withdrawn, and additional attempts were made to identify the correct plane of placement; however, the bent needle tip was subsequently identified.A second solyx blue device was opened, and a new delivery device from that kit was used to complete the left-sided placement of the original solyx blue mesh.Following the procedure, the patient has been feeling pain and discomfort.

• 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: 24094934
• Report Number: 2124215-2026-03191
• Device Sequence Number: 16037384
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)280922(10)37522124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068507010
• Device Catalogue Number: M0068507010
• Device Lot Number: 0037522124
• 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: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Date Device Manufactured: 09/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female