MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 ARTIFICIAL URINARY SPHINCTER; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400162
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for balloon: (b)(4).D4 unique identifier (udi) for cuff: (b)(4).
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this artificial urinary sphincter (aus) due to the device was old and it was not working, during surgery it was reported erosion at the cuff site.The aus was explanted, the physician decided not to place a new cuff at this time and allow the urethra to heal completely.There is no additional information reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The components were visually examined; meanwhile the pump and balloon were also leak and functionally tested.The cuff was identified to have folds and a tear from tool/sharp instrument damage at the cuff tab.The pump adaptor junction and tubing had scaling identified; and it did not pass the functional testing as the pressure output reading was below specification; the pump passed leakage testing.Regarding the balloon, it was identified to be scaled at the bottom of the shell and on the adaptor junction and it did not pass functional testing as the output showed a pressure above specification.The balloon passed leak testing.Based on the available information and analysis results, the functional problems found with the pump and balloon could have caused or contributed to a decrease in the product performance.Additionally, the reported patient symptom is a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned for the reported erosion, while a conclusion code of cause traced to component failure was assigned to the finding related to the pump and balloon.Balloon: model number/catalog number: 72400024.Serial number: unknown.Batch/lot number: 381825017.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Cuff: model number/catalog number: 72400161.Serial number: unknown.Batch/lot number: 374787014.Model/catalog description: belt cuff fgs 4.5 cm.Unique identifier (udi) #: (b)(4).Pump: model number/catalog number: 72400098.Serial number: unknown.Batch/lot number: 383424005.Model/catalog description: control pump fgs.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this artificial urinary sphincter (aus) due to the device was old and it was not working, during surgery it was reported erosion at the cuff site.The aus was explanted, the physician decided not to place a new cuff at this time and allow the urethra to heal completely.There is no additional information reported.

• 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: 22811875
• Report Number: 2124215-2025-55938
• Device Sequence Number: 20747495
• Product Code: EZY
• UDI-Device Identifier: 00878953000732
• UDI-Public: (01)00878953000732(17)071031(10)358830008
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 10/31/2007
• Device Model Number: 72400162
• Device Catalogue Number: 72400162
• Device Lot Number: 358830008
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN 72400024 / LOT 381825017; BALLOON: UPN 72400024 / LOT 381825017; CUFF: UPN 72400161 / LOT 374787014; CUFF: UPN 72400161 / LOT 374787014
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male