MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	72404132
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100224143.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100153458.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced worsening urinary incontinence.The pump was not cycling, and the device exhibited fluid loss.During revision surgery, while the patient was positioned in the dorsal lithotomy position, the outline of the cuff was visible in the perineum, suggesting insufficient tissue coverage of the cuff.The device was explanted, and the cuff was found to have a visible hole that was identified as the source of the fluid loss, resulting in the reported incontinence.A new aus was implanted.The physician suspected that the rupture may have been caused by prolonged sitting or bicycle riding, as the patient was a cyclist.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced worsening urinary incontinence.The pump was not cycling, and the device exhibited fluid loss.During revision surgery, while the patient was positioned in the dorsal lithotomy position, the outline of the cuff was visible in the perineum, suggesting insufficient tissue coverage of the cuff.The device was explanted, and the cuff was found to have a visible hole that was identified as the source of the fluid loss, resulting in the reported incontinence.A new aus was implanted.The physician suspected that the rupture may have been caused by prolonged sitting or bicycle riding, as the patient was a cyclist.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100224143.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100153458.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the cuff and pump of this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected and tested for leaks.The cuff had a tear rom tool/sharp instrument damage along the lateral edge of the cuff shell towards the cuff tab.Cuff had wear at a fold.The cuff had fluid loss due to the tear from sharp instrument damage.The pump was visually inspected, leak and functionally tested.The pump kink resistant tubing (krt) has worn down to the filament.The pump passed both leakage and functional test.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 urinary incontinence, hole/perforate and fluid leak 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 and analysis results, the sharp instrument damage found on the device is considered a secondary failure, so the allegation of hole/perforated and fluid leak is unable to be confirmed.Therefore, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS 800 Artificial Urinary Sphincter
• Common Device Name: Device incontinence mechanical/hydraulic
• 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: 25806730
• Report Number: 2124215-2026-37516
• Device Sequence Number: 17605367
• Product Code: EZY
• UDI-Device Identifier: 00878953003108
• UDI-Public: (01)00878953003108(17)240217(10)1100088932
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/17/2024
• Device Model Number: 72404132
• Device Catalogue Number: 72404132
• Device Lot Number: 1100088932
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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: 72 YR
• Patient Sex: Male