BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Internal Organ Perforation (1987)
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Event Date 02/08/2019 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an advantage system device was implanted during a tension-free vaginal tape placement with cystoscopy procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence.The patient tolerated the procedure well.On (b)(6) 2019, the patient had a cystoscopy and removal of tension-free vaginal tape procedure due to a bladder perforation.During the procedure, the cystoscope was performed and a small area where tape was visualized on the right side of the bladder just inside the bladder neck.Ther was a minimal amount of clot present.The vaginal tape was visualized without difficulty and was removed easily.The patient was awakened, extubated, and transferred to the recovery room in stable condition.
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Manufacturer Narrative
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Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2019, was chosen as the best estimate based on the date of the revision surgery.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: imdrf patient code e211401 captures the reportable event of bladder perforation.Imdrf patient code e0505 captures the reportable event of minimal amount of clot.Imdrf impact code f2303 captures the reportable event of removal of tension-free vaginal tape.
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Search Alerts/Recalls
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