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

Model Number	720163-03
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspecting this sling and its packaging during the implant procedure, the surgeon determined it was contaminated, and it was not used as a result.The procedure was completed with implant of another of the same procedure was completed by implanting an alternate sling.No patient complications were reported.
Event or Problem Description
It was reported that upon inspecting this sling and its packaging during the implant procedure, the surgeon determined it was contaminated, and it was not used as a result.The procedure was completed with an alternative sling device.No patient complications were reported.
Event or Problem Description
It was reported that upon inspecting this sling and its packaging during the implant procedure, the surgeon determined it was contaminated, and it was not used as a result.The procedure was completed with an alternative sling device.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field h6: device codes.

• 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: 21586403
• Report Number: 2124215-2025-15285
• Device Sequence Number: 18359801
• Product Code: OTM
• UDI-Device Identifier: 00191506003999
• UDI-Public: (01)00191506003999(17)270601(10)35279066
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K211847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 720163-03
• Device Catalogue Number: 720163-03
• Device Lot Number: 0035279066
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 07/14/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/06/2025; 08/05/2025
• Date Device Manufactured: 07/17/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male