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

Model Number	72400164
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) cuff was too loose.As a result, the patient was still experiencing urinary incontinence.The aus cuff was explanted, and a new smaller cuff was implanted.There were 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: 20350127
• Report Number: 2124215-2024-61455
• Device Sequence Number: 15467182
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: 00878953000756
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 10/02/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 1100234031
• 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: 09/05/2024
• Initial Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 12/14/2022
• 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 1100214683; CONTROL PUMP, UPN 72404127, LOT 1100222215
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male