LYNX ULTRA SYSTEM
Report
- Report Number
- 2124215-2025-90670
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- November 12, 2025
- Report Date
- February 13, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTN
- UDI-DI
- 00191506007676
- PMA / PMN Number
- K211223
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2770547 | LYNX ULTRA SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET | OTN | BOSTON SCIENTIFIC CORPORATION | M0068503060 | 0036470211 | 00191506007676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |