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

Model Number	M0068502120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Anxiety (2328); Dysuria (2684)
Date of Event	12/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advantage fit blue system device was implanted in a procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.Additionally, during the same surgery, an additional cystocele repair was performed.During the procedure, a cystoscopy was performed confirming correct sling placement and absence of any bladder penetration.On (b)(6) 2024, the patient had a follow-up medical appointment.During consultation, the patient indicated experiencing burning when urinating, nocturnal urinary frequency and pain following the sling placement.The patient noted day-to-day difficulties including asthenia and daily vulvar burns.The patient was admitted at the pain center for follow up as analgesics were not efficient.In (b)(6) 2024, the patient noted that infections and urinary inflammation had become more frequent until becoming daily symptoms.The patient also experienced vulvodynia, pudendal neuralgia, burning, bladder inflammation.The patient alleged the pain had intensified and prevented her from walking and driving which led to anxiety.There have not been any further actions taken in the health care facility for treating the patient.There was no additional information regarding the patient outcome to date.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2330 captures the reportable event of intensified pain.Imdrf patient code e1310 captures the reportable event of infections that become more frequent until becoming daily symptoms.Imdrf patient code e2326 captures the reportable event of bladder inflammation.Imdrf patient code e1301 captures the reportable event of burning during urination.Imdrf impact code f1202 captures the reportable event of the patient being prevented from walking and driving due to pain which led to her anxiety.

• Brand Name: ADVANTAGE FIT 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19050932
• Report Number: 2124215-2024-19143
• Device Sequence Number: 15280898
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 07/10/2026
• Device Model Number: M0068502120
• Device Catalogue Number: 850212
• Device Lot Number: 0031988358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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: Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female