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

Model Number	M0068502120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the plastic sheath detached.The procedure was completed with another of the same device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h5: device code a0501 captures the reportable event of plastic sheath detachment.
Event or Problem Description
It was reported that, during the procedure using an advantage fit blue system device, the plastic sheath detached.The procedure was completed with another of the same device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h5: device code a0501 captures the reportable event of plastic sheath detachment.
Additional Manufacturer Narrative
Device code a0501 captures the reportable event of plastic sheath detachment.Upon receipt at our quality assurance laboratory, this advantage fit blue system device underwent a thorough analysis.Visual inspection of the device revealed that the mesh was intact and still within the sleeve; however, one of the dilators was separated from the sleeve.Based on the information available and analysis results, the reported allegation of the sleeve detachment is confirmed through product analysis.A conclusion code of adverse event related to procedure was assigned to this investigation since it is likely that excessive pulling force was applied during the placement of the mesh, resulting in the analyzed device condition of the dilator being detached.
Event or Problem Description
It was reported that, during the procedure using an advantage fit blue system device, the plastic sheath detached.The procedure was completed with another of the same device.No patient complications were reported as a result of the event.

• Brand Name: ADVANTAGE FIT BLUE SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 19949333
• Report Number: 2124215-2024-49266
• Device Sequence Number: 18384167
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• 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): 11/07/2024

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: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0032792016
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 10/18/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/30/2024; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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