BOSTON SCIENTIFIC - MARLBOROUGH 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 Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant indicated that the device is implanted and will not 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 sis system was implanted during a sling procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was difficult to "deploy the mesh off the carrier." the physician reported that the release mechanism was a little stiff.Additional clarification of the event could not be obtained.Most likely, when deploying the delivery device to deposit the mesh carrier into the muscle, the mesh carrier was difficult to release from the shaft tip of the delivery device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Search Alerts/Recalls
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