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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA Back to Search Results
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.
 
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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 Key18003108
MDR Text Key326475619
Report Number3005099803-2023-05740
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729774044
UDI-Public08714729774044
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081275
Number of Events Reported1
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 NumberM0068507000
Device Catalogue Number850-700
Device Lot Number0030619619
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/29/2023
Initial Date FDA Received10/25/2023
Supplement Dates Manufacturer Received10/24/2023
Supplement Dates FDA Received11/08/2023
Date Device Manufactured11/29/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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