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	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a150205 captures the reportable event of difficulty advancing the device through the patient's tissue.Imdr f device code a040609 captures the reportable code of shaft tip bent.Block h11: the complaint device was not returned; therefore, no physical or visual analysis could be performed.As a result, the reported device performance allegation could not be confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Additionally, 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 instructions.A risk review was completed and confirmed that the event of "difficult to advance and bent" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Because the adverse event occurred during the procedure and the device had no influence on the event, a conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during the midurethral sling procedure using a solyx device, the device may have hit a bone and become bent.The procedure was completed using another of the same device and there were no patient complications reported.

• 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: 24537004
• Report Number: 2124215-2026-12703
• Device Sequence Number: 9026618
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)281012(10)37687053
• 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
• 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): 03/06/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/06/2026
• 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: Unknown