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

Model Number	72400162
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced infection at the cuff.The existing aus was previously explanted and now it was being replaced.There were no device issues and no further patient complications.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced infection at the cuff.The aus was explanted and later replaced on another date.There were no device issues and no further patient complications.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• 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: 20506110
• Report Number: 2124215-2024-65936
• Device Sequence Number: 12826521
• Product Code: EZY
• UDI-Device Identifier: 00878953000732
• UDI-Public: 00878953000732
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 72400162
• Device Catalogue Number: 72400162
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON 72400024; BALLOON 72400024; PUMP 72400098; PUMP 72400098
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown