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

Model Number	M0068507010
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a150201 captures the reportable event of mesh/carrier assembly failure to deploy.
Event or Problem Description
It was reported that, during a stress urinary incontinence procedure using a solyx sis system, the surgeon had difficulty loading the device into the trocar.The device was eventually placed but it would not deploy.The procedure was completed with a new device.There were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a150201 captures the reportable event of mesh/carrier assembly failure to deploy.Block h11: upon receipt at our quality assurance laboratory, this solyx sis system device underwent a thorough analysis.Visual analysis of the device did not find any defects on the delivery device of the mesh.A review of the device history record (dhr) indicated that the device met all manufacturing specifications and is unlikely to have an issue related to manufacturing.Based on the information available and analysis results, the device complaint or problem could not be confirmed.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that during a stress urinary incontinence procedure using a solyx sis system, the surgeon had difficulty loading the device into the trocar.The device was eventually placed but it would not deploy.The procedure was completed with a new device.There were no patient complications reported.

• Brand Name: SOLYX SIS SYSTEM
• 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: 19643849
• Report Number: 2124215-2024-40072
• Device Sequence Number: 6624721
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• 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): 08/16/2024

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 Lot Number: 0033883521
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White