BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed 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 an advantage fit system was used during a mid-uretheral sling procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician placed the sling into the patient and felt that there was an issue with the patient's anatomy.There was difficulty advancing the device into the patient.Subsequently, the physician decided to stop using the device and completed the procedure with a transobturator sling.There were no patient complications 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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