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

Model Number	72400163
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom of incontinence is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) was experiencing persistent urinary incontinence following implantation.Approximately one month after the procedure, an attempt was made to activate the device without success.A subsequent attempt was made during which the balloon was observed to empty; however, the cuff did not fill, and urethral coaptation was not achieved.The pump was reported to fill and empty, but fluid was not delivered to the cuff, and the cuff remained unchanged.There were no further patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for balloon is (b)(4).Concomitant product udi for pump is (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.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.Based on the information available the cause that contributed to the reported event cannot be established, therefore a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) was experiencing persistent urinary incontinence following implantation.Approximately one month after the procedure, an attempt was made to activate the device without success.A subsequent attempt was made during which the balloon was observed to empty; however, the cuff did not fill, and urethral coaptation was not achieved.The pump was reported to fill and empty, but fluid was not delivered to the cuff, and the cuff remained unchanged.There were no further patient complications reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) was experiencing persistent urinary incontinence following implantation.Approximately one month after the procedure, an attempt was made to activate the device without success.A subsequent attempt was made during which the balloon was observed to empty; however, the cuff did not fill, and urethral coaptation was not achieved.The pump was reported to fill and empty, but fluid was not delivered to the cuff, and the cuff remained unchanged.There were no further patient complications reported.
Additional Manufacturer Narrative
This report is being submitted to correct the adverse event/product problem field (b1), date of event field (b3), other relevant history field (b7) in section b, adverse event/product prob; concomitant product/therapy field (c2/d10) in section d, suspect medical device; concomitant information (h11), device analysis in field (h11) in section h, device manufactures only.Model number/catalog number: 72400024, batch/lot number: 1100553610, model/catalog description: balloon fgs 61-70 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72400098 , batch/lot number: 1100621547, model/catalog description: control pump fgs, 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.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.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 is known risk associated with this device type and indicated as such in the instructions for use.A risk review was completed and confirmed that the event of urinary incontinence, fluid leak, mechanical issue, and failure to activate was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of unable to exclude device problem was assigned to this investigation.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation (ncep-00181844) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.

• 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: 23887758
• Report Number: 2124215-2025-92891
• Device Sequence Number: 11929331
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: (01)00878953000749(17)280509(10)1100300291
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2026

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: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 1100300291
• Was Device Available for Evaluation?: No
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 01/06/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/06/2026; 09/18/2026
• Date Device Manufactured: 05/11/2023
• 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: 1100553610; PUMP: UPN: 72400098 / LOT: 1100621547
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male