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	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a mid-urethral sling procedure using an advantage fit ultra device, the physician felt a tear in the sling material.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of tear in mesh.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of tear in mesh.Block h11: upon receipt at our quality assurance laboratory, this advantage fit ultra system underwent a thorough analysis.Visual inspection of the device revealed that the mesh assembly contained one dilator with its sleeve no centering tab attached, and the mesh was outside the sleeve.Furthermore, the leader loop inside the sleeve was torn and the mesh was stretched.Based on the information available and analysis results, the reported allegation of the mesh damaged was confirmed through product analysis.Additionally, the leader loop was torn, and the mesh was stretched was confirmed through product analysis.A conclusion code of adverse event related to procedure was assigned to this investigation since it is likely that procedural conditions, such as user handling and technique during placement or adjusting of the device, resulted in excessive force on the mesh causing it to stretch leading to the leader loop to tear as well, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that, during a mid-urethral sling procedure using an advantage fit ultra device, the physician felt a tear in the sling material.The procedure was completed with another of the same device.No patient complications were 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: 20266597
• Report Number: 2124215-2024-58142
• Device Sequence Number: 11604313
• Product Code: OTN
• UDI-Device Identifier: 00191506007669
• UDI-Public: 00191506007669
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/11/2024

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: 850216
• Device Lot Number: 0033217238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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 Sex: Female