BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problems
Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that solyx sis system device was used during a sling for uterine suspension procedure performed on (b)(6) 2020 for the treatment of uterine prolapse and urine leakage.According to the complainant, during the procedure, the mesh detached from the mesh carrier when the device was deployed through the patient's obturator.The detached mesh was not retrieved from the patient.The procedure could not be completed due to the device problem; however, there is a plan to reschedule the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Event Description
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It was reported to boston scientific corporation that solyx sis system device was used during a sling for uterine suspension procedure performed on (b)(6), 2020 for the treatment of uterine prolapse and urine leakage.According to the complainant, during the procedure, the mesh detached from the mesh carrier when the device was deployed through the patient's obturator.The detached mesh was not retrieved from the patient.The procedure could not be completed due to the device problem; however, there is a plan to reschedule the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block e1 initial reporter facility name: (b)(6) block h6: problem code 3191 is being used to capture the reportable issue of cancelled procedure.A visual examination of the returned solyx sis system revealed that both mesh carriers were detached from the mesh and were not returned; confirming the reported event of mesh carrier detachment.Additionally, there was a damage of the mesh material and there was a residue present on it.The geometry of the material showed evidence of being stretched.There was a residue on the delivery device.No damage to the shaft, handle and delivery device were noted.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that the sling detached during placement in the obturator.It is likely the procedural factors such as procedural debris in the dissection pathway, contributed to the user experiencing difficulty advancing the mesh carrier to the target anatomy, and exerting excessive force resulting in the tearing and stretching of the mesh material and the carrier detachment.Therefore, the investigation concluded 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 event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
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