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

Model Number	72400163
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experience recurrent incontinence.A fibroscopy was performed, revealing a cuff with an occlusive appearance; however, subsequent pelvic x-ray imaging showed an empty balloon.Therefore, the aus was considered nonfunctional, and the patient underwent a surgical procedure to remove and replace the device.Upon removal, the aus was tested, revealing a healthy balloon and a leak at the cuff.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The cuff was visually inspected, and leak tested.The visual inspection revealed folds on the cuff, and the leak test confirmed fluid loss caused by a tear resulting from wear at a fold.The pump was subjected to visual, leak, and functional testing; all three tests passed, with no damage or leakage identified, and the pump was found to be fully functional.Based on the available information and analysis results, the fluid leak observed in the cuff could have caused or contributed to the reported clinical observation of urinary incontinence and fluid leakage.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experience recurrent incontinence.A fibroscopy was performed, revealing a cuff with an occlusive appearance; however, subsequent pelvic x-ray imaging showed an empty balloon.Therefore, the aus was considered nonfunctional, and the patient underwent a surgical procedure to remove and replace the device.Upon removal, the aus was tested, revealing a healthy balloon and a leak at the cuff.No additional patient complications were 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: 23271474
• Report Number: 2124215-2025-71499
• Device Sequence Number: 18519191
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: (01)00878953000749(17)210427(10)132215011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 12/01/2025

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: 04/27/2021
• Device Model Number: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 0132215011
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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: 1000341158.; BALLOON: UPN: 72400024 / LOT: 1000341158.; PUMP: UPN: 72400098 / LOT: 1000346428.; PUMP: UPN: 72400098 / LOT: 1000346428.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Unknown