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

Model Number	72400098
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572); Swelling/ Edema (4577)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced recurrent incontinence and swelling in the genital area.During the outpatient visit, the physician verified that the control pump was retained in the lower part of the scrotum, and upon exposure, it was completely exposed from the scrotum.The physician scheduled a removal surgery for (b)(6) 2025.The physician confirmed that the device was operating normally, and there were no further patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned artificial urinary sphincter (aus) underwent a comprehensive analysis.Microscopic examination revealed no damage or abnormalities; the pump, cuff, and balloon passed the test.Leakage examination revealed no leaks were detected; the pump, cuff, and balloon passed the test.Functional examination revealed the pump and cuff passed functional testing; the balloon was not functionally tested due to missing lot information.The reported extrusion, urinary incontinence, swelling, and pump migration are recognized risks associated with the use of this device and are documented in the instructions for use.Based on the available information, the investigation was concluded with a determination of known inherent risk of device.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced recurrent incontinence and swelling in the genital area.During the outpatient visit, the physician verified that the control pump was retained in the lower part of the scrotum, and upon exposure, it was completely exposed from the scrotum.The physician scheduled a removal surgery for (b)(6) 2025.The physician confirmed that the device was operating normally, and there were no further patient complications.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter aus experienced recurrent incontinence and swelling in the genital area.During the outpatient visit, the physician verified that the control pump was retained in the lower part of the scrotum, and upon exposure, it was completely exposed from the scrotum.The device was explanted.There were no further patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned artificial urinary sphincter (aus) underwent a comprehensive analysis.Microscopic examination revealed no damage or abnormalities; the pump, cuff, and balloon passed the test.Leakage examination revealed no leaks were detected; the pump, cuff, and balloon passed the test.Functional examination revealed the pump and cuff passed functional testing; the balloon was not functionally tested due to missing lot information.The reported extrusion, urinary incontinence, swelling, and pump migration are recognized risks associated with the use of this device and are documented in the instructions for use.Based on the available information, the investigation was concluded with a determination of known inherent risk of device.Correction to field b2: outcomes attrib to adv event correction to field b5: describe event or problem correction to field h6: impact codes detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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: 21882716
• Report Number: 2124215-2025-22332
• Device Sequence Number: 7899919
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 07/24/2025

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 Model Number: 72400098
• Device Catalogue Number: 72400098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/27/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/24/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown