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

Model Number	M0068503000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Perforation (2001); Dysuria (2684); Insufficient Information (4580)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system device was implanted into the patient during a cystoscopy with modified spiral sling procedure performed on (b)(6), 2017, for the treatment of stress incontinence.There were no complications noted and the patient was brought to the pacu in stable condition at the conclusion of the procedure.On (b)(6), 2020, the patient presented for cystoscopy with repair of urethral diverticulum and partial excision of mesh sling.The indication for the procedure was dysuria.The patient was admitted and was brought to the operative suite.Cystoscopy procedure was performed and found no focal areas of erythema, papillary lesion or bladder calculi.The ureteral orifices were in normal position.However, when the urethra was inspected using the 12-degree lens, there were indentation and mass-effect in the posterior bladder wall but with no definite diverticulum or erosion.But when switched to the 70-degree lens, evidence of a possible diverticular opening in the region of the mid urethra was observed.Cystoscope was removed and a foley catheter was placed into the bladder.A 1% lidocaine with epinephrine was injected to the vaginal mucosa and an incision was made with a scalpel.The tissue was noted to be hypervascular, and there was a significant inflammatory reaction noted.The posterior flap of the vagina was carefully dissected off of the anterior wall, the urethra and endopelvic fascia.A clear fluid from a small pinhole opening in the region of the mid urethra leaked.The patent was then placed in a steep trendelenburg position and noticed a relatively widemouth diverticulum of the urethra, and a partially calcified sub urethral sling appears to have eroded into the urethra, with a diverticulum extending out laterally on either side.The sling was cut in the midline.Each sling portion was dissected out laterally past the level of the diverticulum and then cut.Once dissected, tenotomy scissors were used to excise the mucosa of the diverticulum.A running 3-0 vicyrl suture was placed through the muscular mucosal area of the urethra, closing in a transverse fashion from one side to the other.The endopelvic fascia was closed in a second running suture of 3-0 vicryl overlying the first closure.A third 3-0 vicryl layer of closure, inverting the second layer with the third layer in a running fashion was made.Hemostasis was maintained.The foley catheter was removed, and cystoscopy was performed circumferentially with adequate visualization of all mucosa.There was no evidence of injury to the bladder, bladder neck by the dissection and a nice urinary output from both ureters were noted.The bladder was drained, and the cystoscope was removed.A 16 french foley catheter was placed into the bladder and left to gravity drainage returning clear return.The vaginal incision was closed with a 3-0 vicryl running suture x2 and a betadine-soaked vaginal packing was applied.The patient was returned to supine position, awoken from general anesthesia, extubated and transported to the recovery room in stable condition having tolerated the procedure well.
Additional Manufacturer Narrative
Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following imdrf patient codes and impact code capture the reportable events of: e2006 - erosion, e2326 - inflammation, e2401- injury, (nos) to capture urethral diverticulum, e2114 - perforation, ureter/urethra, f1903 - device explantation.

• Brand Name: LYNX 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17548027
• Report Number: 3005099803-2023-04280
• Device Sequence Number: 20497482
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• 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): 08/15/2023

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: 08/02/2020
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0020966695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female