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

Model Number	72404135
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) was explanted due to recurring incontinence.The device was removed and replaced.There were no additional patient complications reported.
Additional Manufacturer Narrative
Update to b5: describe event or problem.Update to c2/d110: concominent devices.Update to h6 device codes : inadequacy of device shape or/size.Updated to d4 model number, catalog number, lot number, expiration date, and unique identifier.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with recurring incontinence.The original cuff appeared to be too big.The device was removed and replaced.There were no additional patient complication reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• 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: 19499142
• Report Number: 2124215-2024-34972
• Device Sequence Number: 7908040
• Product Code: EZY
• UDI-Device Identifier: 00878953003139
• UDI-Public: 00878953003139
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 07/25/2024

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 Expiration Date: 02/21/2025
• Device Model Number: 72404135
• Device Catalogue Number: 72404135
• Device Lot Number: 1100264394
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 07/06/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 02/22/2023
• 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: BALLOONUPN: 7240024LOT: 1100396748; PUMPUPN: 72404127LOT: 1100398163
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Unknown