BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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