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

Model Number	72400167
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented recurring incontinence due to the device was not performing as expected.After removal of the device it was observed that the cuff was punctured.The aus was explanted and replaced.There were no additional patient complications reported.

• 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: 20926453
• Report Number: 2124215-2024-79032
• Device Sequence Number: 14775744
• Product Code: EZY
• UDI-Device Identifier: 00878953000787
• UDI-Public: 00878953000787
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 08/13/2019
• Device Model Number: 72400167
• Device Catalogue Number: 72400167
• Device Lot Number: 0893557001
• 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: 11/26/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 08/13/2014
• 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 0168054010; PUMP: UPN 72400098 / LOT 0157509014
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female