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

Model Number 850-700

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Urinary Retention (2119)

Event Date 12/21/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 333051660
• Report Number: 2124215-2024-00879
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 45 KG