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); 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 09/11/2020 |
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.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device is disposed and 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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Note: this manufacturer report pertains to the first of three devices used during the same procedure.It was reported to boston scientific corporation that three solyx sis system devices were used during a sling procedure performed on (b)(6) 2020 to treat stress urinary incontinence.According to the complainant, one of the mesh carriers detached from the mesh during insertion on the patient's left side.The detached piece remained inside the patient and there was no attempt made to retrive it.A second and third device were opened and the same issue occurred.The procedure was aborted due to the device problem and there is no plan to complete the procedure at this time.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 fine and fully recovered.
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Search Alerts/Recalls
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