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

Model Number M0068507010

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a stress urinary incontinence (sui) procedure performed (b)(6) 2023, for the treatment of stress urinary incontinence.During the procedure, it was reported that the sling got stuck on the trocar on one side, which most likely suggests that the mesh carrier failed to deploy.The procedure was completed using another solyx blue sis, and there were no patient complications as a result of the event.

Manufacturer Narrative

Block h6: imdrf device code a150201 captures the reportable event of the sling being stuck on the trocar on one side.

Manufacturer Narrative

Block h6: imdrf device code a150201 captures the reportable event of the sling being stuck on the trocar on one side.Block h10: a solyx blue sis system, consisting of a delivery device and a mesh, was returned and analyzed.Upon visual inspection, it was discovered that the deployment mechanism of the delivery device was deformed.The mesh was returned with both mesh carriers attached, but it was stretched on one side.The functional test revealed that the device would not deploy the mesh.With all the available information, boston scientific concludes the reported event of mesh did not deploy was confirmed.It is likely that procedural conditions, such as user handling technique during placement or advancement of the mesh, resulted in the deployment mechanism becoming deformed leading to the mesh becoming stretched.Therefore, the investigation concludes that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a stress urinary incontinence (sui) procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.During the procedure, it was reported that the sling got stuck on the trocar on one side, which most likely suggests that the mesh carrier failed to deploy.The procedure was completed using another solyx blue sis, and there were no patient complications as a result of the event.

• 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 ; 5086834015
• MDR Report Key: 18013189
• MDR Text Key: 326632456
• Report Number: 3005099803-2023-05768
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Model Number: M0068507010
• Device Catalogue Number: 850-701
• Device Lot Number: 0031592478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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