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

Model Number	720133-01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) cuff connecting tube presented a crack.A surgical procedure was performed to replace the cuff and pump.There were no further patient complications.
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) cuff connecting tube presented a crack.A surgical procedure was performed to replace the cuff and pump.There were no further patient complications.
Additional Manufacturer Narrative
The cuff connecting tube implant reported with a crack; therefore, the allegation cannot be established without device analysis.However, the artificial urinary sphincter balloon component was returned.Upon receipt of this artificial urinary sphincter (aus) balloon at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis did not identify damage or abnormalities on balloon.The component was tested.The balloon component successfully passed leakage test; however, it did not pass the functional test, the output pressure reading was below specification.Concomitant product udi for pump is (b)(4), concomitant product udi for balloon is ((b)(4).

• 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: 21814515
• Report Number: 2124215-2025-22259
• Device Sequence Number: 7569031
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: (01)00878953005461(17)220203(10)1000391074
• 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): 06/18/2025

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: 02/03/2022
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1000391074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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: 0024, LOT: 1000400856; BALLOON: UPN: 0024, LOT: 1000400856; PUMP: UPN: 0098, LOT: 1000279697; PUMP: UPN: 0098, LOT: 1000279697
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown