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

Model Number	M0068507010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a040609 captures the reportable code of shaft tip bent.
Event or Problem Description
It was reported that, during a sling procedure using a solyx blue device, the needle tip was bent.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that, during a sling procedure using a solyx blue device, the needle tip was bent.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a040609 captures the reportable code of shaft tip bent.Upon receipt at our quality assurance laboratory, this solyx blue device underwent a thorough analysis.Visual inspection found that the delivery device tip was bent.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.Based on the information available and analysis results, the reported event of "delivery device tip was bent" was confirmed.It is likely that procedural conditions, such as user handling technique during placement or advancement of the mesh with excessive manipulation or force resulted in the delivery device tip becoming bent.A conclusion code of adverse event related to procedure was assigned to this investigation as it indicates that the adverse event occurred during the procedure and the device had no influence on the 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: 22523236
• Report Number: 2124215-2025-45329
• Device Sequence Number: 12777072
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)271015(10)35072113
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/28/2025

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: 0035072113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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