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	Insufficient Information (4580)
Date of Event	01/15/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advantage system device was implanted into the patient during posterior colporrhaphy, perineorrhaphy, placement of a mid-urethral sling, and cystourethroscopy procedures performed on (b)(6) 2013, for the treatment of rectocele and urodynamic stress incontinence.The patient's external genitalia were found to be normal upon anesthetic examination.The patient lacked both a uterus and a cervix.Rectocele was discovered.Apical and anterior support were normal and good.The bladder mucosa seemed normal and healthy during cystoscopy after the tension-free vaginal tape trocars were passed, with no injuries or defects in the bladder.Bilateral visualization of the ureteral orifice was performed.The ureterovesical junction and urethral interior appeared normal as well.Furthermore, the doctor confirmed the presence of a rectocele during the rectal examination, and after the rectocele repair, they performed another digital examination, enabling them to confirm the absence of an enterocele.A rectal exam was performed once the surgery was completed.No suture injury was palpable through the rectal mucosa.In addition, no complications were observed throughout the procedure, and the patient was woken from anesthesia, extubated, and transported to the post-anesthesia care unit in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2013, 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).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.

• 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): 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: 17205927
• Report Number: 3005099803-2023-03279
• Device Sequence Number: 17809036
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 06/26/2023

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: 10/31/2015
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00001046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female