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	Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an advantage fit blue system was implanted to treat stress urinary incontinence symptoms.Immediately after the implantation, the patient experienced acute urinary retention and significant pain.Several stents were placed during the days following the implant procedure; however, voiding was not possible.The patient indicated expressing the desire to remove the sling; however, it was noted that the medical personnel recommended loosening the device instead.Approximately a week after implant, the patient was hospitalized after attempting to loosen the tight sling vaginally.A surgical procedure was performed in which it was noted that the strip had become excessively loose and eventually came off; therefore, the gynecologist opted to remove the existing sling and implant a new device.Note: this report pertains to one of two devices implanted on the same patient.Refer to manufacturer report number 2124215-2025-25023 for the second advantage fit blue system device.
Additional Manufacturer Narrative
Block h6: patient code e1309 captures the reportable event of immediate acute urinary retention.Patient code e2330 captures the reportable event of pain.Impact code f1905 captures the reportable event of removal of existing 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: 21922470
• Report Number: 2124215-2025-24971
• Device Sequence Number: 15721635
• 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,Company Representative
• 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