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 Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Abnormal Vaginal Discharge (2123)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an advantage fit system device was implanted during a retropubic mid-urethral sling and cystourethroscopy procedure performed on (b)(6) 2019.Due to exposed vaginal mesh sling, vaginal pain, vaginal discharge, and vaginal bleeding, the patient underwent release, excision, extraction of exposed vaginal mesh sling, ureterolysis, and cystourethroscopy on (b)(6) 2022.During the procedure, it was noted that the sling was tightly adherent to the urethra on the patient's left side.The patient tolerated the procedure well and was taken to the recovery room in a stable condition.
Additional Manufacturer Narrative
Block h6: patient code e2006 captures the reportable event of exposed vaginal mesh sling.Patient code e2330 captures the reportable event of pain.Patient code e1401 captures the reportable event of vaginal discharge.Patient code e0506 captures the reportable event of vaginal bleeding.Impact code f1905 captures the reportable event of extraction of exposed vaginal mesh sling.

• 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: 20698399
• Report Number: 2124215-2024-70089
• Device Sequence Number: 19772285
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/15/2024

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: 07/18/2022
• Device Model Number: M0068502120
• Device Catalogue Number: M0068502120
• Device Lot Number: 0024134525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/15/2024
• Date Device Manufactured: 07/19/2019
• 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: 38 YR
• Patient Sex: Female