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 Codes	Hematoma (1884); Internal Organ Perforation (1987)
Date of Event	02/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advantage system device was implanted during a tension-free vaginal tape placement with cystoscopy procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence.The patient tolerated the procedure well.On (b)(6) 2019, the patient had a cystoscopy and removal of tension-free vaginal tape procedure due to a bladder perforation.During the procedure, the cystoscope was performed and a small area where tape was visualized on the right side of the bladder just inside the bladder neck.Ther was a minimal amount of clot present.The vaginal tape was visualized without difficulty and was removed easily.The patient was awakened, extubated, and transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2019, was chosen as the best estimate based on the date of the revision surgery.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: imdrf patient code e211401 captures the reportable event of bladder perforation.Imdrf patient code e0505 captures the reportable event of minimal amount of clot.Imdrf impact code f2303 captures the reportable event of removal of tension-free vaginal tape.

• 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 ; 5086834015
• MDR Report Key: 18007863
• Report Number: 3005099803-2023-05772
• Device Sequence Number: 17805095
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2019
• 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): 10/25/2023

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: 05/28/2021
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0022180865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• 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: 45 YR
• Patient Sex: Female