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

Model Number	720163-02
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Incontinence (4572)
Date of Event	03/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day postoperative the patient experienced urinary retention with a sling device.A month later the patient experienced recurring incontinence with the device.The physician suspected the sling might have slipped.A surgical procedure was scheduled for (b)(6) 2021 to remove the sling and implant an artificial urinary sphincter (aus).No device malfunctions were suspected.The patient was expected to fully recover.
Event or Problem Description
It was reported that one day postoperative the patient experienced urinary retention with a sling device.It was indicated that the patient was unable to void at all; therefore, the patient was catheterized for an additional week.A month later the patient experienced recurring incontinence with the device.The physician suspected the sling might have slipped but there were no device malfunctions with the sling.A surgical procedure was performed in which a new artificial urinary sphincter (aus) was implanted.The patient was expected to fully recover.
Additional Manufacturer Narrative
Updated: describe event or problem.Investigation summary: based on the information available, the cause that contributed to the reported urinary retention and urinary incontinence cannot be established as the product is not available for analysis.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the slings-mens instructions for use (ifu).The sling-mens ifu lists urinary incontinence and urinary retention as a potential adverse event(s) associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Common Device Name: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11929393
• Report Number: 2124215-2021-15575
• Device Sequence Number: 16929473
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: Lay User/Patient
• Device Expiration Date: 12/10/2021
• Device Model Number: 720163-02
• Device Catalogue Number: 720163-02
• Device Lot Number: 0026696546
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR