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

Model Number	72404127
Medical Device Problem Codes	Migration (4003); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) pump component was too high up during the healing process and the patient could not reach the pump.A surgical procedure was performed during which the device was repositioned.Upon explant the physician identified an air bubble in the pump and there was no leak in the system.The physician suspected the air bubble was potentially attributed to the previous surgery during pump component preparation.No additional information was provided.
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100881936.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404130.Serial number: n/a.Batch/lot number: 1100623039.Model/catalog description: belt cuff fgs 4.0 cm iz.Unique identifier (udi) #: (b)(4).

• 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: 50288810
• Report Number: 2124215-2026-44175
• Device Sequence Number: 9678407
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)280215(10)1100901449
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100901449
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 02/15/2026
• 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: 73 YR
• Patient Sex: Male