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	Defective Device (2588)
Health Effect - Clinical Codes	Micturition Urgency (1871); Scar Tissue (2060); Prolapse (2475); Dyspareunia (4505); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).The explanting physician is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e1405 - captures the reportable event of dyspareunia.F2401 - captures the reportable event of urinary hesitancy.E2015 - captures the reportable event of vaginal atrophy.E1715 - captures the reportable event of scarring.The following imdrf impact code capture the reportable event of: f1903 - captures the reportable event of sling excision.
Event or Problem Description
It was reported to boston scientific corporation that a lynx blue system device was implanted into the patient during cystoscopy and native tissue cystocele repair, transvaginal tape, and sling placement procedure performed on (b)(6) 2019, for the treatment of stress incontinence and cystocele.On (b)(6) 2021, the patient underwent a sling excision and cystoscopy procedure to address various urinary issues.These included urinary hesitancy, overactive bladder, dyspareunia, and evidence of sling migration on magnetic resonance imaging (mri).Before the procedure, the vaginal mucosa was noted to be atrophic, and there was scarring at the bladder neck.However, the cervix appeared normal.During a rectal exam, no masses were detected, but a small distal rectocele was found with upward rectal pressure.The sling was the only mesh palpable in the anterior/posterior compartments; however, no mesh exposure was identified.During the procedure, the mesh was noted to be indenting the sub-urethral tissue.The sling was excised until no visible or palpable mesh could be noted.A cystourethroscopy was performed, and it showed normal bilaterally effluxing ureters, a normal urethra, and normal bladder mucosa after full distention.No abnormalities were noted during the inspection.The patient was placed in a supine position, awakened, and taken to the recovery room in stable condition, having tolerated the procedure well.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17775393
• Report Number: 3005099803-2023-05024
• Device Sequence Number: 20375951
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 09/19/2023

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: 12/06/2021
• Device Model Number: M0068503010
• Device Catalogue Number: 73193
• Device Lot Number: 0023051215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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: 61 YR
• Patient Sex: Female