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

Model Number	720163-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure for urinary incontinence, when the physician began tensioning sling using conservative tensioning pressure, one of the fixation sutures popped.Doctor tensioned again and the left sling arm ripped between the widest part of the sling and the first chevron.Due to this, the procedure was completed using another sling.There were no patient complications.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, no visual or functional testing was able to be completed.With all the available information, boston scientific concludes that the reported complaint was not confirmed.Based on the information available, a conclusion code cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure for uronary incontinence, when the physician began tensioning sling using conservative tensioning pressure, one of the fixation sutures popped.Doctor tensioned again and the left sling arm ripped between the widest part of the sling and the first chevron.Due to this, the procedure was completed using another sling.There were no patient complications.

• 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: 21800176
• Report Number: 2124215-2025-21367
• Device Sequence Number: 18205114
• Product Code: OTM
• UDI-Device Identifier: 00191506003999
• UDI-Public: (01)00191506003999(17)270801(10)35935639
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 0035935639
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 04/25/2025
• Date Device Manufactured: 09/25/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male