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

Model Number	720163-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Burning Sensation (2146)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an advance sling experienced urinary retention.The patient stated that a catheter was placed following the implant surgery, which was later removed during a post-operative visit.A second catheter was placed after the patient underwent a four-hour fluid intake test (16/32 oz) and was unable to void.An ultrasound revealed that the patient was retaining 365 cc of fluid.The second catheter was subsequently removed, and the patient was able to void; however, he is now experiencing a weak stream, burning, and pain.No additional information was provided.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The reported patient symptoms of burning sensation, pain and urinary retention are known risks associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an advance sling experienced urinary retention.The patient stated that a catheter was placed following the implant surgery, which was later removed during a post-operative visit.A second catheter was placed after the patient underwent a four-hour fluid intake test (16/32 oz) and was unable to void.An ultrasound revealed that the patient was retaining 365 cc of fluid.The second catheter was subsequently removed, and the patient was able to void; however, he is now experiencing a weak stream, burning, and pain.No additional information was provided.

• 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: 24125313
• Report Number: 2124215-2026-03712
• Device Sequence Number: 14949072
• Product Code: OTM
• UDI-Device Identifier: 00191506003999
• UDI-Public: (01)00191506003999(17)271001(10)37675050
• Combination Product (Y/N): N
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: Lay User/Patient
• Device Model Number: 720163-03
• Device Catalogue Number: 720163-03
• Device Lot Number: 0037675050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 06/17/2025
• 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 Age: 64 YR
• Patient Sex: Male