BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a solyx single incision sling system was used during a mid-urethral sling procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician was trying to implant the sling on the patient's left side and after pulling the delivery device handle, the mesh carrier would not release from the shaft tip.Consequently, the physician could not properly anchor the device into the patient's obturator.The procedure was completed with another solyx single incision sling system.There were no patient complications as a result of the event.
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