MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of march 16, 2023, was chosen as the best estimate based on the date a cystoscopy procedure was performed.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf patient code e2326 captures the reportable event of chronic inflammation.Imdrf patient code e1311 captures the reportable event of pelvic floor dysfunction.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf impact code f2203 captures the reportable event of cystoscopy procedure.
Event or Problem Description
It was reported that an advantage fit blue system and upsylon device were implanted during a robotic sacro colpopexy, advantage fit sub urethral sling, suprapubic bonanno catheter placement, cystoscopy, and robotic lysis of adhesions procedure performed on (b)(6) 2022, for the treatment of cystocele, rectocele, enterocele, and stress incontinence.Due to urinary tract infection, chronic cystitis, and pelvic floor dysfunction, the patient was scheduled for a cystoscopy procedure on (b)(6) 2023.During the procedure, a flexible cystoscope was passed per urethra.Chronic cystitis was seen over the bladder neck and trigone consistent with chronic inflammation.The patient has had a bladder lift and sling with mesh.Additionally, pelvic exams consistently found pelvic floor dysfunction and dyspareunia.Note: this report is the second of two complaints that pertain to the same event (mfr report #3005099803-2023-05465 and mfr.Report #2124215-2024-27942).

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19378242
• Report Number: 2124215-2024-27942
• Device Sequence Number: 7703462
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/22/2024

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: 09/30/2024
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C004308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Female