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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a solyx blue sis system device was used during a mid-urethral sling procedure on (b)(6) 2026.During the insertion, the physician attempted to pass the first side of the solyx sling.The mesh carrier caught on the mesh and failed to deploy properly.As a result, the mesh became excessively stretched, and the sling could not be used.The procedure was completed with another solyx sling.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of mesh did not deploy properly.
Additional Manufacturer Narrative
Block h6: imdrf device code (b)(6) captures the reportable event of mesh did not deploy properly.Block h11: with all the available information, bsc concludes that the reported material deformation and failure to deploy was defined in the risk documentation.The device was not returned for evaluation; therefore, a technical analysis could not be performed.The device history record (dhr) confirmed that the device met all material, assembly, and performance specifications prior to release with no manufacturing deviations identified.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow the instructions.A review was completed and confirmed that the events of material deformation and failure to deploy were defined in the risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the available information and absence of evidence indicating a device malfunction or manufacturing issue, the complaint could not be confirmed, and it is most likely that excessive force applied during use contributed to the outcome; therefore, the most probable cause classification is adverse event related to procedure.
Event or Problem Description
It was reported that a solyx blue sis system device was used during a mid-urethral sling procedure on (b)(6) 2026.During the insertion, the physician attempted to pass the first side of the solyx sling.The mesh carrier caught on the mesh and failed to deploy properly.As a result, the mesh became excessively stretched, and the sling could not be used.The procedure was completed with another solyx sling.There were no patient complications reported as a result of this event.

• 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: 24594197
• Report Number: 2124215-2026-14094
• Device Sequence Number: 18760585
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)280219(10)35889831
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 04/15/2026

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: 0035889831
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 02/19/2025
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 64 KG