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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a lynx blue system device was used during a retropubic mid-urethral sling procedure performed on (b)(6) 2018, for the treatment of stress urinary incontinence.On (b)(6) 2019, the patient was diagnosed with sling mesh exposure.A surgical procedure was performed in which after, the mesh was visualized, it was grasped, and the epithelium dissected away from the elements of the pubovesicocervical fascial bilaterally.The sling was then trimmed, and it was confirmed that there were no further patient complications.On (b)(6) 2023, the patient presented recurring urinary incontinence.A surgical procedure to implant a new sling device was planned; however, when cystourethroscopy was performed it was noticed that a remnant piece of the original mesh was extruding into the urethra.The new implant was then aborted, and the previous sling was able to be fully removed with no further patient complications.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of january 2, 2019, was chosen as the best estimate based on the date when the mesh was first exposed.Block h6: imdrf patient code e2006 captures the reportable event of sling mesh exposure.Imdrf impact code f1901 captures the reportable event of urethorlysis.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f06 captures the reportable event of the implant of the new sling being cancelled due to the erosion seen with the original mesh.

• 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: 19041142
• Report Number: 2124215-2024-19150
• Device Sequence Number: 12898676
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: M0068503010
• Device Catalogue Number: 73193
• Device Lot Number: 0022239382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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
• Patient Age: 47 YR
• Patient Sex: Female