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

Model Number	M0068502000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/09/2022
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) 2022, was chosen as a best estimate based on the date of mesh removal.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.Andrew robers east texas medical center 161 mt pelia rd, martin, tn united states 75426 phone: (b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain the following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported to boston scientific that an advantage system was implanted into the patient on (b)(6) 2013, during a mid-urethral sling and cystourethroscopy procedure for the treatment of symptomatic stress urinary incontinence.She was observed in the recovery room and was given a trial of voiding.Verbal and written instructions were provided.On (b)(6) 2022, she underwent excision of mid-urethral sling mesh, placement and removal of the left open-ended ureteral catheter, and cystourethroscopy due to pain related to mid-urethral sling mesh and pain in that area during physical examination.The patient was counseled regarding the risks, benefits, alternatives, and indications of the procedure and elected to proceed with mesh excision.Findings of the procedure showed brisk bilateral ureteral efflux noted after cannulization of the left ureter with the left ureteral catheter.No bladder injuries and bladder sutures were noted.The urethra was intact.The mesh was removed from the inferior pubic ramus to the inferior pubic ramus.

• Brand Name: ADVANTAGE 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18753473
• Report Number: 2124215-2024-09012
• Device Sequence Number: 17069673
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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): 02/21/2024

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: 03/31/2015
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00000570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Female