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

Model Number	M0068503060
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Erosion (1750); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g4: the lynx ultra system device received fda clearance through two separate 510(k) approvals: k211223 and k231549.Block h6: the following imdrf device codes capture the reportable events of: a0414 - mesh torn.The following imdrf patient codes capture the reportable events of: e2006 - erosion, e0515 - dissection.The following imdrf impact codes capture the reportable events of: f1908 - prolonged procedure.
Event or Problem Description
It was reported that during a mid-urethral sling procedure using a lynx ultra system device, the sling became tangled while being pulled through the anatomy, and the mesh appeared shredded.The physician noted that the integrity of the mesh appeared compromised and did not feel comfortable proceeding with implantation, so the sling was removed, resulting in a prolonged procedure.The patient experienced dissection and suprapubic extrusion.The procedure was completed using another device of the same model.
Additional Manufacturer Narrative
Block h11: correction to blocks b1: adverse event/product problem, b2: outcomes attrib to adv event, h6: patient codes, and g2: report source.Block g4: the lynx ultra system device received fda clearance through two separate 510(k) approvals: k211223 and k231549.Block h6: the following imdrf device codes capture the reportable events of: a0414 - mesh torn.The following imdrf impact codes capture the reportable events of: f1908 - prolonged procedure.
Event or Problem Description
It was reported that during a mid-urethral sling procedure using a lynx ultra system device, the sling became tangled while being pulled through the anatomy, and the mesh appeared shredded.The physician noted that the integrity of the mesh appeared compromised and did not feel comfortable proceeding with implantation, so the sling was removed, resulting in a prolonged procedure.The patient experienced dissection and suprapubic extrusion.The procedure was completed using another device of the same model.Additional information received on december 15, 2025: there were no patient complications.Dissection was performed, then the sling was placed, but the sling stretched and the physician wasn't happy with it, so the sling was removed.The only patient impact was extended the extended procedure time to place a second sling.
Additional Manufacturer Narrative
Block h11: upon receipt at our quality assurance laboratory, this lynx ultra device underwent a thorough analysis.Visual inspection of the device revealed the mesh was torn near the centering tab.Based on the information available and analysis results, the reported allegation of the mesh being torn was confirmed through product analysis; however, the reported allegation of mesh twisted could not be confirmed through product analysis.A conclusion code of adverse event related to procedure was assigned to this investigation since the adverse events occurred during the procedure and the device had no influence on event.Block g4: the lynx ultra system device received fda clearance through two separate 510(k) approvals: k211223 and k231549.Block h6: the following imdrf device codes capture the reportable events of: a0414 - mesh torn.
Event or Problem Description
It was reported that during a mid-urethral sling procedure using a lynx ultra system device, the sling became tangled while being pulled through the anatomy, and the mesh appeared shredded.The physician noted that the integrity of the mesh appeared compromised and did not feel comfortable proceeding with implantation, so the sling was removed, resulting in a prolonged procedure.The patient experienced dissection and suprapubic extrusion.The procedure was completed using another device of the same model.Additional information received on december 15, 2025: there were no patient complications.Dissection was performed, then the sling was placed, but the sling stretched and the physician wasn't happy with it, so the sling was removed.The only patient impact was extended the extended procedure time to place a second sling.

• Brand Name: LYNX 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: 23792335
• Report Number: 2124215-2025-90670
• Device Sequence Number: 17571059
• Product Code: OTN
• UDI-Device Identifier: 00191506007676
• UDI-Public: (01)00191506007676(17)280507(10)36470211
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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: M0068503060
• Device Catalogue Number: M0068503060
• Device Lot Number: 0036470211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/14/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/30/2025; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown