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

Model Number	72400163
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not functioning properly.Upon inspection, a crack was found in the cuff connecting tube.A surgical procedure was performed during which the existing device was explanted and replaced with a new cuff (4.5).There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant products implanted at the time of the event: model number/catalog number: 72400098 serial number: n/a batch/lot number: 1100829345 model/catalog description: control pump fgs unique identifier (udi) #: (01)00878953000688(17)301109(10)1100829345 model number/catalog number: 72400024 serial number: n/a batch/lot number: 1100738200 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #: (01)00878953000626(17)300529(10)1100738200 model number/catalog number: 72400162 serial number: n/a batch/lot number: 1100915229 model/catalog description: belt cuff fgs 5.0 cm unique identifier (udi) #: (01)00878953000732(17)310302(10)1100915229.

• 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: 50914680
• Report Number: 2124215-2026-51368
• Device Sequence Number: 17580800
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 1100766243
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 07/22/2025
• 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 Sex: Unknown