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

Model Number M0068507000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050 captures the reportable investigation results of the shaft tip being detached and found stuck in one of the mesh carriers.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a procedure performed on an unknown date.It was reported that the end broke off of the mesh, which most likely suggests that the mesh carrier was detached.This event has been deemed reportable based on the investigation results: the shaft tip detached and was found stuck in one of the mesh carriers.Please see block h10 for full investigation details.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a procedure performed on an unknown date.It was reported that the end broke off of the mesh, which most likely suggests that the mesh carrier was detached.This event has been deemed reportable based on the investigation results: the shaft tip detached and was found stuck in one of the mesh carriers.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a050 captures the reportable investigation results of the shaft tip being detached and found stuck in one of the mesh carriers.Block h10: the returned solyx sis system device was analyzed, and it was found visually with the delivery device tip that was stuck in one of the mesh carriers.Therefore, the reported complaint is confirmed.With all the available information, boston scientific concludes that after analysis, it is likely that procedural conditions, such as user handling technique during/after placement of a mesh carrier dart, resulted in excessive force on the delivery device and mesh carrier causing the delivery device tip to detach.The probable cause selected 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.

• 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: 18003108
• MDR Text Key: 326475619
• Report Number: 3005099803-2023-05740
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

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: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0030619619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/08/2023
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1