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

Model Number	M0068503010
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Urinary Incontinence (4572)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a150205 captures the reportable event of difficult to advance.Patient code e211401 captures the reportable event of bladder perforation.Impact code f1001 captures the reportable event of procedure cancelled.
Event or Problem Description
It was reported that, during a procedure, a lynx device was used.Due to the challenging anatomy, the trocar inadvertently punctured the bladder, causing the procedure to be halted and rescheduled to ensure patient safety and allow for proper complication management.The physician was planning to complete the procedure once the patient heals.Currently, the patient has been experiencing stress urinary incontinence.
Event or Problem Description
It was reported that, during a procedure, a lynx device was used.Due to the challenging anatomy, the trocar inadvertently punctured the bladder, causing the procedure to be halted and rescheduled to ensure patient safety and allow for proper complication management.The physician was planning to complete the procedure once the patient heals.Currently, the patient still presents the stress urinary incontinence symptoms.
Additional Manufacturer Narrative
Block h6: device code a150205 captures the reportable event of difficult to advance.Patient code e211401 captures the reportable event of bladder perforation.Block h11: upon receipt at our quality assurance laboratory, this lynx blue system underwent a thorough analysis.Visual inspection of the device revealed no issues.Additionally, the blue centering tab was attached, and two dilators and association loops were also present.The mesh had no defects.Based on the information available, the complaint was not confirmed since the analysis of the returned device did not find any issues with the device.However, since the adverse events occurred during the procedure and the device had no influence on event, the most probable cause of adverse event related to patient condition is selected since an existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.Block h11: correction to block h6: patient code.

• Brand Name: LYNX 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: 21395466
• Report Number: 2124215-2025-07879
• Device Sequence Number: 20981278
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068503010
• Device Catalogue Number: M0068503010
• Device Lot Number: 0034919738
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female