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

Model Number M0068503010

Device Problem Defective Device (2588)

Patient Problems Micturition Urgency (1871); Scar Tissue (2060); Prolapse (2475); Dyspareunia (4505); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 09/03/2019

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 323753496
• Report Number: 3005099803-2023-05024
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female