MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANCE? XP; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number	720163-03
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was discharged the following day after the procedure.Concerns were noted regarding the sling device, which appears to be somewhat loose.When the patient stands, the weight distribution reportedly causes a prolapse into the perineal area.No additional patient complications were reported.

• Brand Name: ADVANCE? XP
• Common Device Name: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22856237
• Report Number: 2124215-2025-57749
• Device Sequence Number: 8889380
• Product Code: OTM
• UDI-Device Identifier: 00191506003999
• UDI-Public: (01)00191506003999(17)270801(10)36677044
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K211847
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 720163-03
• Device Catalogue Number: 720163-03
• Device Lot Number: 0036677044
• 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: 07/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 03/12/2025
• 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
• Patient Sex: Unknown