MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	72404130
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with an artificial urinary sphincter (aus) experienced recurring incontinence.A surgical procedure was performed during which the cuff was explanted and replaced with a smaller size cuff.No additional information was provided.
Event or Problem Description
It was reported that this patient with an artificial urinary sphincter (aus) experienced recurring incontinence.The physician did not believe the device caused or contributed to the incontinence.A surgical procedure was performed during which the cuff was explanted and replaced with a smaller size cuff.The most likely/suspected cause of the recurring incontinence was either atrophy or incorrect sizing of the implant during original implantation.Additionally, the physician did not believe the cuff was initially placed in the correct location.No additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100741130 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #: (b)(4) model number/catalog number: 72404127 serial number: n/a batch/lot number: 1100714367 model/catalog description: control pump fgs iz unique identifier (udi) #: (b)(4) b3: date is unknown, so estimated date was entered.
Additional Manufacturer Narrative
Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100741130.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404127.Serial number: n/a.Batch/lot number: 1100714367.Model/catalog description: control pump fgs iz.Unique identifier (udi) #: (b)(4).B3: date is unknown, so estimated date was entered.

• 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 ; +1(508)652-1217
• MDR Report Key: 50937759
• Report Number: 2124215-2026-51788
• Device Sequence Number: 13450859
• Product Code: EZY
• UDI-Device Identifier: 00878953003085
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Expiration Date: 09/06/2026
• Device Model Number: 72404130
• Device Catalogue Number: 72404130
• Device Lot Number: 1100584796
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 09/06/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male