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 Problem (3009)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of aborted procedure.
Event or Problem Description
It was reported that during a mid-urethral sling procedure, the sling was not tight enough and could not be re-tensioned due to the anchor that did not seat correctly.The surgeon then had to abort the procedure as there were no more solyx or other mini-slings in the hospital.Furthermore, the space under the urethra was too narrow for the width of a retropubic sling.The vaginal mucosa was thin, and tunnels were too small, which would make it hard to get the retropubic sling to fit in the space.The solyx mesh was then removed, leaving the mesh carriers in place bilaterally.This event is being reported for an aborted or cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
H6: impact code f1001 captures the reportable event of aborted procedure.H11: upon receipt at our quality assurance laboratory, this solyx sis system device underwent a thorough analysis.Only the delivery device was received; the mesh was not returned.Visual inspection of the device did not reveal any visual damage/defect.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Based on the information available and analysis results, the reported event against the mesh could not be confirmed, since only the delivery device was returned with no issues.However, it is likely that during the case some excessive force was used when attempting to remove the sling as the single incision sling is not designed to be removed once placed within the patient.It is also likely that the physician pushed the delivery device instead of pulling the delivery device as instructed in the ifu, causing the anchor to not 'seat correctly.Therefore, all compiled information on this investigation determines that the most probable cause for the issues against the mesh and carrier is unintended use error, indicating that the interaction between the user and the device caused or contributed to the error.
Event or Problem Description
It was reported that during a mid-urethral sling procedure, the sling was not tight enough and could not be re-tensioned due to the anchor that did not seat correctly.The surgeon then had to abort the procedure as there were no more solyx or other mini-slings in the hospital.Furthermore, the space under the urethra was too narrow for the width of a retropubic sling.The vaginal mucosa was thin, and tunnels were too small, which would make it hard to get the retropubic sling to fit in the space.The solyx mesh was then removed, leaving the mesh carriers in place bilaterally.This event is being reported for an aborted or cancelled procedure with a patient under anesthesia or sedation status unknown.

• 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: 20351853
• Report Number: 2124215-2024-59776
• Device Sequence Number: 12758232
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/12/2025

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: 850701
• Device Lot Number: 0033972855
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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: Female
• Patient Weight: 75 KG