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

Model Number	72400163
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for balloon: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the cuff was found.The cuff was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the cuff was found.The cuff was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for balloon: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The balloon was microscopically inspected and leak testing.It was found that the tubing was worn down to the filament.Balloon passed leak and functional testing.Finally, the cuff was microscopically inspected and leak testing, it was observed to have folds.Additionally, the cuff had a hole from wear at a corner of a fold.The cuff did not pass the leakage test due to a leak from wear at a corner of a fold.Based on the information available and analysis results, the hole and leak identified in the cuff could have caused or contributed to the reported clinical observation of mechanical problem.

• 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: 23917325
• Report Number: 2124215-2025-93555
• Device Sequence Number: 18624919
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: (01)00878953000749(17)250203(10)1000391161
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/26/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/03/2025
• Device Model Number: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 1000391161
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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 1000546845; BALLOON: UPN 72400024 / LOT 1000546845; PUMP: UPN 72400098 / LOT 1000529955; PUMP: UPN 72400098 / LOT 1000529955
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male