BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507010 |
Device Problems
Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block h6: imdrf device code a0501 captures the reportable event of delivery system tip detachment of device or device component.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system was used during a solyx implantation of female sling procedure, performed on (b)(6) 2023.During insertion, the device was reported to be fractured/broken.The event is unclear and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the delivery system tip was detached.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system was used during a solyx implantation of female sling procedure, performed on (b)(6) 2023.During insertion, the device was reported to be fractured/broken.The event is unclear and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the delivery system tip was detached.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a0501 captures the reportable event of delivery system tip detachment of device or device component.Block h10: upon receipt at our quality assurance laboratory, this solyx sis system underwent a thorough analysis.The device was visually examined and found that the one of the mesh carrier darts was detached from the mesh.The mesh was also stretched.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, the reported allegation of delivery system tip detachment of device or device component was confirmed.Based on the information available and analysis results, it is likely that procedural conditions, such as user handling technique during/after placement of a mesh carrier dart, resulted in excessive force with the delivery device and mesh carrier causing the dart to detach and the mesh to become stretched.A conclusion code of adverse event related to procedure was assigned to this investigation.
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Search Alerts/Recalls
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