MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device Incontinence Mechanical/Hydraulic

Model Number	72400160
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	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72400098, serial number: n/a, batch/lot number: 1100750700, model/catalog description: control pump fgs, unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024, serial number: n/a, batch/lot number: 1100735606, model/catalog description: balloon fgs 61-70 cm, unique identifier (udi) #: (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.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient's artificial urinary sphincter (aus) was not functioning properly.A surgical procedure was performed during which a crack was found in the cuff connecting tube.The cuff was removed and a new 3.5 cm cuff was implanted; no 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: 25232702
• Report Number: 2124215-2026-27203
• Device Sequence Number: 5017592
• Product Code: EZY
• UDI-Device Identifier: 00878953000718
• UDI-Public: (01)00878953000718(17)300624(10)1100750798
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72400160
• Device Catalogue Number: 72400160
• Device Lot Number: 1100750798
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 07/14/2026; 09/09/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 08/12/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male