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	Premature Activation (1484); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of premature deployment of mesh carrier from the shaft tip.
Event or Problem Description
It was reported that a solyx blue sis system device was used during a placement of midurethral sling with cystoscopy procedure on (b)(6) 2026.During the procedure, while placing the sling on the patients left side, the surgeon attempted to withdraw the delivery device to reposition the trajectory.During this maneuver, the mesh released from the device without releasing with the knob.When the surgeon attempted to remove the mesh, the mesh carrier detached from the mesh and was left inside the patient.No attempts were made to retrieve the retained mesh carrier.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported that a solyx blue sis system device was used during a placement of midurethral sling with cystoscopy procedure on (b)(6) 2026.During the procedure, while placing the sling on the patient's left side, the surgeon attempted to withdraw the delivery device to re-position the trajectory.During this maneuver, the mesh released from the device without releasing with the knob.When the surgeon attempted to remove the mesh, the mesh carrier detached from the mesh and was left inside the patient.No attempts were made to retrieve the retained mesh carrier.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of premature deployment of mesh carrier from the shaft tip.Block h11: with all the available information, bsc concludes that the reported unretrieved device fragments (udf), premature deployment and detachment of device or device component were defined in the risk documentation.The device was not returned for evaluation; therefore, a product analysis could not be performed.A dhr review confirmed that the devices met all material, assembly, and performance specifications.A review was completed and confirmed that the events of unretrieved device fragments (udf), premature deployment and detachment of device or device component were defined in the risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.A review of the device instructions for use (ifu) was completed and the ifu cited: "mesh is considered a permanent implant.Removal of mesh or correction of mesh related complications may involve multiple surgeries." the single incision sling is not designed to be removed.However, the complainant reported that the surgeon attempted to reposition the device.During this attempt, excessive force was likely applied, resulting in detachment of the carrier.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation, as the user-device interaction caused or contributed to the event, including unintended inappropriate use of the device and incorrect sample preparation.

• 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: 24612026
• Report Number: 2124215-2026-14438
• Device Sequence Number: 16035830
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: (01)08714729961901(17)281222(10)38246908
• 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): 04/20/2026

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: 0038246908
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 12/23/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 69 KG