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

Model Number	72404135
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72400023, serial number: n/a , batch/lot number: 1100471676, model/catalog description: balloon fgs 51-60 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404127, serial number: n/a, batch/lot number: 1100776656, model/catalog description: control pump fgs iz, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Recurrent incontinence and positional incontinence, and improperly sized cuff are acknowledged within the directions for use (dfu) and are not related to off-label use or failure to follow instructions.A risk review was completed; altered therapeutic response, and size related complications are defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The reported patient symptom of urinary incontinence is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurring incontinence following the initial cuff placement.A cystoscopy was performed, and the urethra did not show any blanching, suggesting that the cuff may be too loose.A surgical procedure was performed to downsize the cuff.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurring incontinence following the initial cuff placement.A cystoscopy was performed, and the urethra did not show any blanching, suggesting that the cuff may be too loose.A surgical procedure was performed to downsize the cuff.No further patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Model number/catalog number: 72400023, serial number: n/a , batch/lot number: 1100471676, model/catalog description: balloon fgs 51-60 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404127, serial number: n/a, batch/lot number: 1100776656, model/catalog description: control pump fgs iz, unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the cuff of this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected and tested for leaks.The cuff passed visual inspection.No damage or abnormalities were found.No leaks were found in the cuff.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) was reviewed.The reported patient symptom of urinary incontinence was found to be listed in the ifu.A risk review was completed and confirmed that the events of inadequate cuff size/loose cuff and incontinence were 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 and analysis results, the reason for cuff - length too long was likely due to the surgeon choosing the wrong length as it was reported that the urethra did not show any blanching, suggesting that the cuff may be too loose.Based on the information available, a conclusion code of unintended use error caused or contributed to even was assigned to this investigation.

• 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: 24986218
• Report Number: 2124215-2026-22370
• Device Sequence Number: 21458919
• Product Code: EZY
• UDI-Device Identifier: 00878953003139
• UDI-Public: (01)00878953003139(17)270819(10)1100780636
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 72404135
• Device Catalogue Number: 72404135
• Device Lot Number: 1100780636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male