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 Codes	Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a mid-urethral sling procedure using an advantage fit blue system, the physician initially attempted to place the sling on the patient's left side but encountered resistance while advancing the trocar into the retropubic space.After several attempts, the device was successfully passed, and intraoperative cystoscopy confirmed no bladder injury.The physician then attempted placement on the right side and experienced similar difficulty advancing the device as intended.After multiple unsuccessful attempts, the physician elected to open and use a non-boston scientific device to complete the right-sided placement.The advantage fit device was subsequently removed from the left side and replaced with the non-boston scientific device.A repeat cystoscopy confirmed no bladder injury.No patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a150201 captures the reportable event of mesh difficult to deploy.
Additional Manufacturer Narrative
Block h11: correction to block e1: initial reporter email.Block h6: device code a150201 captures the reportable event of mesh difficult to deploy.
Event or Problem Description
It was reported that, during a mid-urethral sling procedure using an advantage fit blue system, the physician initially attempted to place the sling on the patient's left side but encountered resistance while advancing the trocar into the retropubic space.After several attempts, the device was successfully passed, and intraoperative cystoscopy confirmed no bladder injury.The physician then attempted placement on the right side and experienced similar difficulty advancing the device as intended.After multiple unsuccessful attempts, the physician elected to open and use a non-boston scientific device to complete the right-sided placement.The advantage fit device was subsequently removed from the left side and replaced with the non-boston scientific device.A repeat cystoscopy confirmed no bladder injury.No patient complications reported.
Event or Problem Description
It was reported that, during a mid-urethral sling procedure using an advantage fit blue system, the physician initially attempted to place the sling on the patient's left side but encountered resistance while advancing the trocar into the retropubic space.After several attempts, the device was successfully passed, and intraoperative cystoscopy confirmed no bladder injury.The physician then attempted placement on the right side and experienced similar difficulty advancing the device as intended.After multiple unsuccessful attempts, the physician elected to open and use a non-boston scientific device to complete the right-sided placement.The advantage fit device was subsequently removed from the left side and replaced with the non-boston scientific device.A repeat cystoscopy confirmed no bladder injury.No patient complications reported.
Additional Manufacturer Narrative
Correction to block h6: device codes.Block h6: imdrf device code a150205 captures the reportable event of difficulty advancing the device through the patient's anatomy.Block h11: the complaint device was not returned; therefore, no physical or visual analysis could be performed.As a result, the reported device performance allegation could not be confirmed.The device history record (dhr) confirmed that the device met all material, assembly and performance specification.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.A risk review was completed and confirmed that the event of difficulty advancing the device was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Record and manufacturing reviews identified no additional information or evidence of a device malfunction or process-related defect.As the adverse event occurred during the procedure and was not influenced by the device, the most probable cause was determined to be procedure-related.

• 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: 24029787
• Report Number: 2124215-2026-01715
• Device Sequence Number: 15786659
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: (01)08714729961925(17)281013(10)37701586
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/09/2026

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: M0068502120
• Device Lot Number: 0037701586
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 03/13/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/09/2026
• Date Device Manufactured: 10/14/2025
• 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: 47 YR
• Patient Sex: Female