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

Model Number M006850200051

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Urinary Retention (2119); Stenosis (2263); Dysuria (2684)

Event Date 11/30/2007

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage system was implanted during a total vaginal hysterectomy, anterior and posterior repair and suburethral sling with mesh procedures performed on (b)(6) 2005 to treat a patient with symptomatic pelvic relaxation and stress urinary incontinence.On (b)(6) 2007, the patient experienced urinary retention (difficulty voiding), urethral stenosis and erosion of the sling into the urethra.The patient also complained of pelvic pain.Upon bladder scan, the patient was found to have a markedly-elevated residual, essentially to be in urinary retention.A cystoscopy with urethral dilatation and removal of the foreign body from the urethra procedures were performed.After informed consent was given, the patient was taken to the operating room.The patient received preoperative antibiotic coverage.The patient then underwent a general anesthesia.The patient was prepped and draped in standard fashion in a relaxed dorsal lithotomy position.A #21-french cystoscope was attempted to be advanced via the urethra into the bladder.However, resistance was met.Therefore the physician proceeded with a #18-french and advanced up to #36-french.Upon putting in each sound, the physician felt a roughened appearance to the urethra.In the physician's description it almost felt like there was a stone in the urethra.The physician was then able to proceed with cystoscopy.The scope was easily placed into the bladder.The bladder was examined in a systemic manner.All portions of the mucosa were visualized.Both ureteral orifices were seen with normal configuration and location.Upon pulling back and examining the urethra, it became very obvious that in the mid urethra, almost distal to the urethra, there was evidence of a polypropylene-appearing sling.The patient had a sling in another location approximately two years prior.Along the base of the urethra in the are of the distal urethra, the sling was resting.In the physician's assessment, this must surely account for the patient's difficulty in voiding as well as the pain felt by the patient with voiding.Therefore, the physician proceeded with attempt at removing the sling.Through the cystoscope, some cystoscopic scissors were used to cut the edge of the sling on both sides.Grasping forceps were then used to remove parts of the sling.Once this procedure was complete, the physician was able to put the scope in easily and no roughened appearance was noted.The physician suspected there was still some sling material in the lateral mucosa of the urethra.However, the portion of the sling which had eroded through the urethra had been removed.This suture material was sent as a specimen as foreign body.Once complete, there was no resistance in the urethra.There were no obvious other abnormalities.The bladder still looked good.Therefore, the scope was removed.A #18-french foley catheter was placed into gravity drainage with return of very light-pink urine.The patient was then awakened and transferred to the stretcher and to the recovery room in good condition.The patient tolerated the procedure well.

Manufacturer Narrative

This event was reported by the patient's legal representation.The implant surgeon is (b)(6).(b)(4).

• Brand Name: ADVANTAGE 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15535740
• MDR Text Key: 301098905
• Report Number: 3005099803-2022-05417
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729719564
• UDI-Public: 08714729719564
• 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: 10/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Model Number: M006850200051
• Device Catalogue Number: 850-200-05
• Device Lot Number: 0ML5080904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female