MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068502120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of july 22, 2022, was chosen as a best estimate based on the date of mesh implant.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).The revising physician is: (b)(6).Block h6: the following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported to boston scientific corporation that an advantage fit blue system was implanted into the patient during a sacrospinous ligament fixation procedure performed on (b)(6) 2022.During the same surgery, anterior colporrhaphy, suburethral sling, cystoscopy, posterior colporrhaphy, and enterocele repair vaginal approach procedures were also performed.On (b)(6) 2025, the patient was diagnosed with mixed stress and urge urinary incontinence.She underwent partial excision of mesh.During the same procedure, cystourethroscopy and anterior colporrhaphy procedures were also performed.During the procedure, palpation of the urethra revealed no evidence of mesh extrusion.The cystoscope sheath was advanced into the bladder and then withdrawn slowly with the scope tip directed downward until a subtle "step-off" was used to identify the mesh.A midline incision was made at the level of the mid-urethra and bladder neck, and the vaginal epithelium was carefully dissected off the periurethral fascia to create tissue flaps for closure following mesh excision.The mesh was identified and isolated from the urethra using right-angle clamps, then further exposed through a combination of blunt and sharp dissection.The mesh was incised at the midline, tracked laterally toward both fornices, and subsequently removed.Approximately 4 cm of mesh was excised.Attention was then directed to the anterior colporrhaphy.The vaginal muscularis and adventitia were plicated using multiple horizontal mattress sutures, tied in the midline.Following completion of the plication, cystoscopy was performed to confirm ureteral patency.The bladder appeared normal, and both ureteral orifices demonstrated efflux of clear orange urine.The vaginal mucosa was trimmed bilaterally and closed with a running 2-0 vicryl suture.Hemostasis was excellent.The foley catheter was removed, and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.

• Brand Name: ADVANTAGE FIT BLUE SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24336853
• Report Number: 2124215-2026-08311
• Device Sequence Number: 4914404
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: (01)08714729961925(17)250517(10)29422181
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2025
• Device Model Number: M0068502120
• Device Catalogue Number: M0068502120
• Device Lot Number: 0029422181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 05/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female