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

Model Number	72400162
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).
Event or Problem Description
It was reported that the went to the clinic because this artificial urinary sphincter (aus) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cuff connecting tube was identified.The cause of crack in the cuff connecting tube was not detailed by the hospital.The cuff was removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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.Based on the information available and analysis results, the allegation of mechanical issue and hole/perforated is unable to be confirmed.The device history record (dhr) review was unable to be performed as the lot number was not provided.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the went to the clinic because this artificial urinary sphincter (aus) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cuff connecting tube was identified.The cause of crack in the cuff connecting tube was not detailed by the hospital.The cuff was removed and replaced.No patient complications were 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: 23306420
• Report Number: 2124215-2025-72779
• Device Sequence Number: 5827587
• Product Code: EZY
• UDI-Device Identifier: 00878953000732
• UDI-Public: (01)00878953000732
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 72400162
• Device Catalogue Number: 72400162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 1100353025; BALLOON: UPN: 72400024 / LOT: 1100353025; PUMP: UPN: 72400098 / LOT: 1100383140; PUMP: UPN: 72400098 / LOT: 1100383140
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male