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	Malposition of Device (2616); Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150205 captures the reportable event of difficulty advancing the device through the patient's tissue.Imdrf patient code e2114 captures the reportable event of vaginal perforation.
Event or Problem Description
It was reported that during the procedure, the obturator was not properly aligned, resulting in a vaginal wall perforation during sling manipulation.The implanted mesh was immediately removed, and a new solyx sling was reinserted to complete the procedure.No further patient complications were reported following the incident.
Event or Problem Description
It was reported that during the procedure, the obturator was not properly aligned, resulting in a vaginal wall perforation during sling manipulation.The implanted mesh was immediately removed, and a new solyx sling was reinserted to complete the procedure.No further patient complications were reported following the incident.
Additional Manufacturer Narrative
This report is being submitted to correct the device codes (h6) in section h, device manufacturers only.Block h6: imdrf patient code e2114 captures the reportable event of vaginal perforation.

• 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: 23560989
• Report Number: 2124215-2025-81370
• Device Sequence Number: 10132534
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 0036774955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 06/17/2025
• 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 Sex: Female