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

Model Number	850-700
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Internal Organ Perforation (1987); Urinary Retention (2119)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e211401 captures the reportable event of perforation, organs.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code e1309 captures the reportable event of urinary retention post-void residual volume (pvr) resulting in the need for catheterization.
Event or Problem Description
It was reported to boston scientific corporation that a solyx sis system was used during a stress urinary incontinence procedure in the bladder, performed on (b)(6) 2023.During the procedure, when the physician attempted to push the solyx anchor into the periurethral tissue, it perforated the bladder.The physician attempted to pop the anchor into the muscles, however, it was not advancing, and when tried to remove, there was resistance.When the physician had successfully removed the anchor, it was noticed that the mesh was stretched from pulling the anchor out of the bladder.Another solyx sis system was opened and used to complete the procedure.The patient had a large blood clot and a bladder perforation which was cauterized using a bugbee during cystoscopy.The bleeding was controlled, and a catheter was left in place.The day after the procedure, the patient had a 50% post-void residual (pvr), so she was taught self-catheterization and scheduled to follow up a week later.When the surgeon last spoke to the patient on (b)(6) 2024, she did not need to self-catheterize and was also not leaking; the patient was reported to be doing well.

• 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: 18527920
• Report Number: 2124215-2024-00879
• Device Sequence Number: 15385333
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• 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
• Report Date (Section B): 01/17/2024

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 Expiration Date: 09/24/2026
• Device Model Number: 850-700
• Device Catalogue Number: 850-700
• Device Lot Number: 0032496303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 45 KG