MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Scar Tissue (2060); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Urethral Stenosis/Stricture (4501)
Date of Event	04/28/2021
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 april 28, 2021, was chosen as a best estimate based on the date of the mesh was implanted.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 patient code captures the reportable event of: e1301 - captures the reportable event of dysuria.E1310 - captures the reportable event of urinary tract infection.E2006 - captures the reportable event of erosion.E1715 - captures the reportable event of scar tissue.E1307 - captures the reportable event of stricture.The following imdrf impact code captures the reportable events of: f1905 - captures the reportable event of mesh revision.
Event or Problem Description
Note: this manufacturer report pertains to the first of the two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and lynx system devices were implanted in the patient during robotic-assisted total laparoscopic hysterectomy with cystoscopy, sacrocolpopexy, perineorrhaphy, and a tension-free mid-urethral sling; there were no intraoperative complications, and the patient left the operating room in stable condition.Following the procedure, the patient had a urethral mesh erosion with scarring and urethral stricture, which presented as dysuria, hematuria, and recurrent urinary tract infections.The patient subsequently underwent a removal or revision of vaginal mesh, cystoscopy and complex urethroplasty on (b)(6) 2025.There was no bladder perforation or intravesical mesh migration, estimated blood loss was 400 ml, no intraoperative complications occurred, the patient tolerated the procedure well, and postoperative status included an indwelling 18f foley catheter with planned removal after 14 days and routine follow-up.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).The revising physician is: (b)(6).The following imdrf impact code captures the reportable events of: f1905 - captures the reportable event of mesh revision.
Event or Problem Description
Note: this manufacturer report pertains to the first of the two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and lynx system devices were implanted in the patient during robotic-assisted total laparoscopic hysterectomy with cystoscopy, sacrocolpopexy, perineorrhaphy, and a tension-free mid-urethral sling; there were no intraoperative complications, and the patient left the operating room in stable condition.Following the procedure, the patient had a urethral mesh erosion with scarring and urethral stricture, which presented as dysuria, hematuria, and recurrent urinary tract infections.The patient subsequently underwent a removal or revision of vaginal mesh, cystoscopy and complex urethroplasty on (b)(6) 2025.There was no bladder perforation or intravesical mesh migration, estimated blood loss was 400 ml, no intraoperative complications occurred, the patient tolerated the procedure well, and postoperative status included an indwelling 18f foley catheter with planned removal after 14 days and routine follow-up.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway H91 C 2NF; EI H91 C2NF
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24337569
• Report Number: 2124215-2026-08343
• Device Sequence Number: 9754461
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)240228(10)C004217
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 02/28/2024
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C004217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 02/06/2021
• 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: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female