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); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced the device not functioning properly.A revision surgery was performed during which the physician confirmed that the cuff had a hole.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for balloon is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for balloon is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).Correction to field b3: date of event correction to field g2: report source correction to field h6: device codes correction to field d6: implant date correction to field c2/d10: concomitant product/therapy.Since the exact event date is unknown, 03/13/2025 was used as an estimated date based on the reported onset occurring two weeks before procedure on (b)(6) 2025.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced the device not functioning properly.A revision surgery was performed during which the physician confirmed that the cuff had a hole.The device was explanted and replaced.There were no patient complications.

• 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: 21892240
• Report Number: 2124215-2025-25482
• Device Sequence Number: 3530295
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: (01)00878953000749(17)240407(10)1000258585
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 04/07/2024
• Device Model Number: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 1000258585
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 04/09/2019
• 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 1000547943; BALLOON UPN 72400024 LOT 1000547943; PUMP UPN 72400098 LOT 1000540801; PUMP UPN 72400098 LOT 1000540801
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male