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

Model Number	720163-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the sling advance xp came off of the trocar.No patient complications were reported.
Event or Problem Description
It was reported that during the implant procedure, the sling advance xp came off of the trocar.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this sling advance xp thorough analysis.The sling was visually inspected.Visual examination revealed that needle passer and sling had been detached; the connectors had been trimmed off from the sling by sharp instrument and one of the tips of the connector was not return for analysis; and the plastic sheath with liner was damage from sharp instrument.Based on the information available and analysis of results, the sharp instrument damage found on the device is considered a secondary failure, so the allegation of device break is unable to be confirmed.However, there are several failure modes of the device that could lead to device break, which include but are not limited to a device malfunction.Based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.

• 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: 20790453
• Report Number: 2124215-2024-72526
• Device Sequence Number: 18095269
• Product Code: OTM
• UDI-Device Identifier: 00191506003999
• UDI-Public: 00191506003999
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K211847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 720163-03
• Device Catalogue Number: 720163-03
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown