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

Model Number	72404127
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: (b)(6).Serial number: n/a.Batch/lot number: 1100845864.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: (b)(6).Serial number: n/a.Batch/lot number: 1100850663.Model/catalog description: belt cuff fgs 4.0 cm iz.Unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a patient implanted with an artificial urinary sphincter (aus) experienced difficulty operating the control pump.A surgical intervention was subsequently performed, during which it was determined that the tubing was wrapped around the pump's deactivation button, preventing both the physician and the patient from deactivating the device.It was suspected that post operative migration of the pump within the scrotum caused the tubing to obstruct the deactivation button.The pump was removed and a new pump was repositioned within the patient's scrotum.There were no patient complications.

• 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: 25394949
• Report Number: 2124215-2026-29913
• Device Sequence Number: 12113726
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)280114(10)1100871226
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: 1100871226
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/04/2026
• Date Device Manufactured: 01/14/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown