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

Model Number	720163-01
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant of this advance xp sling procedure, the physician stated that the trocars were inserted without issue and the sling body was positioned correctly against the urethra.While attempting to remove the plastic protective sleeve, removal on one side was difficult and the contralateral side presented significant difficulty.During this process, the protective plastic sleeve and tyvek paper broke, and fragments remained in the patient.As a troubleshooting measure, the surgeon divided the sling arm from the sling body through the perineal incision and attempted to remove the sling arm from the groin incision with the expectation that the plastic sheath and tyvek paper would be removed; however, these efforts were unsuccessful.The procedure was subsequently abandoned, and the surgeon did not deem it safe to proceed with passing another sling arm or trocar on the affected side.The patient did not experience any signs or symptoms of infection following the procedure.The issue was not present upon opening the package.No patient complications were reported, and the patient was expected to fully recover.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem, correction to field b2: outcomes attrib to adv event, correction to field d6a: implant date.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The detachment of device or device component can be confirmed through the photo attached to the complaint, but the cause could not be determined due to the lack of a product return to analysis.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of unretrieved device fragments (udf), detachment of device or device component, difficult to remove, item left in patient were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during the implant of this advance xp sling procedure, the physician stated that the trocars were inserted without issue and the sling body was positioned correctly against the urethra.While attempting to remove the plastic protective sleeve, removal on one side was difficult and the contralateral side presented significant difficulty.During this process, the protective plastic sleeve and tyvek paper broke, and fragments remained in the patient.As a troubleshooting measure, the surgeon divided the sling arm from the sling body through the perineal incision and attempted to remove the sling arm from the groin incision with the expectation that the plastic sheath and tyvek paper would be removed; however, these efforts were unsuccessful.The procedure was subsequently abandoned, and the surgeon did not deem it safe to proceed with passing another sling arm or trocar on the affected side.The patient did not experience any signs or symptoms of infection following the procedure.The issue was not present upon opening the package.No patient complications were reported, and the patient was expected to fully recover.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• 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: 24553258
• Report Number: 2124215-2026-13035
• Device Sequence Number: 9486019
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: (01)00878953005560(17)271001(10)36877652
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/15/2026

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: Health Professional
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0036877652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 04/07/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male