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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a150205 captures the reportable event of difficult to advance.
Event or Problem Description
It was reported that, during a procedure using a solyx blue device, the device had difficulty advancing.The procedure was completed using another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that, during a procedure using a solyx blue device, the device had difficulty advancing.The procedure was completed using another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h11: upon receipt at our quality assurance laboratory, the solyx blue device underwent a thorough analysis.During the product analysis, it was observed that the mesh carrier was detached, and the mesh was stretched, confirming the complaint.Based on the information available and analysis results, given that mesh placement is largely a blind procedure in which tough muscle, some bone, and occasionally tendons may be encountered, creating resistance during placement--contributed to the issue, a conclusion code of adverse event related to procedure was assigned to this investigation since the adverse events occurred during the procedure and the device had no influence on event.Block h6: device code a150205 captures the reportable event of difficult to advance.

• 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: 21538232
• Report Number: 2124215-2025-12579
• Device Sequence Number: 17917038
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)270930(10)34957500
• 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,Followup
• Report Date (Section B): 09/02/2025

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: 0034957500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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 Age: 63 YR
• Patient Sex: Unknown
• Patient Weight: 56 KG