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

Model Number	72400098
Medical Device Problem Codes	Mechanical Problem (1384); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) visited the clinic for device activation; however, the device did not work.As a result, the patient continued to experience recurrent urinary incontinence.Clinical examinations confirmed that the pump did not maintain the occlusive cuff.No voiding was observed, and urodynamic studies still indicated incontinence.The device remains implanted, and a replacement procedure is scheduled.No additional patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).Correction to field h6: device codes.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of urinary incontinence is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) visited the clinic for device activation; however, the device did not work.As a result, the patient continued to experience recurrent urinary incontinence.Clinical examinations confirmed that the pump did not maintain the occlusive cuff.No voiding was observed, and urodynamic studies still indicated incontinence.The device remains implanted, and a replacement procedure is scheduled.No additional patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the dhr, the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptom of urinary incontinence is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Correction to field h6: impact codes.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) visited the clinic for device activation; however, the device did not work.As a result, the patient continued to experience recurrent urinary incontinence.Clinical examinations confirmed that the pump did not maintain the occlusive cuff.No voiding was observed, and urodynamic studies still indicated incontinence.Several days later, the patient contacted the clinic and stated that he would not be undergoing the procedure with his previous physician.He is currently awaiting delivery of the replacement device to schedule the procedure.The device remains implanted.No additional patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the dhr, the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptom of urinary incontinence is a known risk associated with implant of these device as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) visited the clinic for device activation; however, the device did not work.As a result, the patient continued to experience recurrent urinary incontinence.Clinical examinations confirmed that the pump did not maintain the occlusive cuff.No voiding was observed, and urodynamic studies still indicated incontinence.Several days later, the patient contacted the clinic and stated that he would not be undergoing the procedure with his previous physician.He is currently awaiting delivery of the replacement device to schedule the procedure.As a result, the device was explanted and replaced.No additional patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cuff is (b)(4) and for balloon is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The reported patient symptom of urinary incontinence is a known risk associated with implant of these device as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) visited the clinic for device activation; however, the device did not work.As a result, the patient continued to experience recurrent urinary incontinence.Clinical examinations confirmed that the pump did not maintain the occlusive cuff.No voiding was observed, and urodynamic studies still indicated incontinence.Several days later, the patient contacted the clinic and stated that he would not be undergoing the procedure with his previous physician.He is currently awaiting delivery of the replacement device to schedule the procedure.As a result, the device was explanted and replaced.No additional patient complications have been 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: 22908169
• Report Number: 2124215-2025-59519
• Device Sequence Number: 18125918
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)290925(10)1100600279
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

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 Model Number: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1100600279
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 10/01/2025; 11/27/2025; 02/03/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/23/2025; 10/24/2025; 12/22/2025; 02/27/2026
• Date Device Manufactured: 09/26/2024
• 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 1100587385.; BALLOON: UPN 72400024/LOT 1100587385.; BALLOON: UPN 72400024/LOT 1100587385.; BALLOON: UPN 72400024/LOT 1100587385.; BALLOON: UPN 72400024/LOT 1100587385.; CUFF: UPN 72400162/ LOT 1100460335.; CUFF: UPN 72400162/ LOT 1100460335.; CUFF: UPN 72400162/ LOT 1100460335.; CUFF: UPN 72400162/ LOT 1100460335.; CUFF: UPN 72400162/ LOT 1100460335.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Male