MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT ULTRA SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET

Model Number	M0068502160
Medical Device Problem Codes	Unsealed Device Packaging (1444); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, it was observed that the device box was slightly damaged.Upon opening, the sterile package was found to be partially unsealed, and the device itself appeared slightly dented.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Block g4: the complete premarket/510(k) #: k211223, k231549.Block h6: device code a020503 captures the reportable event of seal compromised.
Additional Manufacturer Narrative
Block h11: upon receipt at our quality assurance laboratory, this advantage fit device underwent a thorough analysis.Visual inspection of the mesh did not reveal any damages or defects.Additionally, the mesh looked unused, and a cut of the product information was returned; however, the claimed damaged box and damaged sterile pouch were not returned.Based on the information available and analysis results, the reported allegations of the packaging seal compromised and incomplete seal could not be confirmed through product analysis since the packaging was not received and the device was received with no defects.A conclusion code of cause not established was assigned to this investigation as the investigation findings do not lead to a clear conclusion about the cause of the reported event.Block g4: the complete premarket / 510(k) #: k211223, k231549 block h6: device code a020503 captures the reportable event of seal compromised.
Event or Problem Description
It was reported that during preparation, it was observed that the device box was slightly damaged.Upon opening, the sterile package was found to be partially unsealed, and the device itself appeared slightly dented.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: ADVANTAGE FIT ULTRA SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• 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: 23408067
• Report Number: 2124215-2025-75900
• Device Sequence Number: 13030806
• Product Code: OTN
• UDI-Device Identifier: 00191506007669
• UDI-Public: (01)00191506007669(17)280610(10)36731699
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211223
• 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
• Report Date (Section B): 12/17/2025

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: M0068502160
• Device Catalogue Number: M0068502160
• Device Lot Number: 0036731699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Patient Age: 60 YR
• Patient Sex: Female