MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANCE? XP; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number	720163-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that he foley catheter used did not reached the vesical space when it was inserted initially, and the balloon dilated specifically the bulbar urethra.The physician chose to abort the procedure since urethra was affected, and a bladder neck narrowness was detected too.No additional information was reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Handle/needle component passed visual inspection.Product analysis was not able to confirm device malfunction.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that he foley catheter used did not reached the vesical space when it was inserted initially, and the balloon dilated specifically the bulbar urethra.The physician chose to abort the procedure since urethra was affected, and a bladder neck narrowness was detected too.No additional information was reported.

• Brand Name: ADVANCE? XP
• Common Device Name: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21699402
• Report Number: 2124215-2025-18136
• Device Sequence Number: 20810785
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: (01)00878953005560(17)250531(10)34480897
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K182169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0034480897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 113 KG