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	Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a second advantage fit blue system was implanted to treat stress urinary incontinence symptoms.This second device was placed after the previous sling had been loosened.After the implantation, the patient indicated experiencing urinary infection, incomplete urination, being forced to urinate standing up, diverted urine stream, dysuria, constant pain that intensifies when walking, and sensations similar to electric shocks and perineal burning.Additionally, the patient noted psychological, family, professional repercussions as the patient has needed to remain on sick leave since the first intervention.Around a month after implant, urine samples were collected and cultured.The culture provided a positive result for citrobacter freundii, leading to antibiotics being prescribed.Approximately two months after implant, a surgical procedure was performed in which the device was attempted to be removed; however, the physician was not able to locate or palpate the device.The procedure was aborted, and the patient was referred to another center to be seen by a specialist.Note: this report pertains to one of two devices implanted on the same patient.Refer to manufacturer report number 2124215-2025-24971 for the first advantage fit blue system device.
Additional Manufacturer Narrative
Block h6: patient code e1310 captures the reportable event of urinary tract infection.Patient code e1309 captures the reportable event of incomplete urination.Patient code e2330 captures the reportable event of pain.Patient code e0206 captures the reportable event of forced to urinate when standing up and urine flows everywhere.Patient code e1301 captures the reportable event of dysuria.Patient code e1705 captures the reportable event of burning sensation.Patient code e1311 captures the reportable event of psychological, family and professional repercussions.Impact code f12 captures the reportable event of serious injury.Impact code f19 captures the reportable event of surgical intervention.Impact code f1001 captures the reportable event of absence of treatment.Impact code f2303 captures the reportable event of medication required.

• 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: 21922473
• Report Number: 2124215-2025-25023
• Device Sequence Number: 9073151
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: (01)08714729961925(17)261105(10)32792016
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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 Model Number: M0068502120
• Device Catalogue Number: M0068502120
• Device Lot Number: 0032792016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 11/06/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG