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

Model Number	72400163
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Malposition of Device (2616)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this artificial urinary sphincter (aus) due to recurring incontinence.The aus was not working.Fluid loss was observed due to a hole in the cuff.The cuff was around the corpora instead of the urethra.The aus was explanted.There were no additional patient complications reported.

• 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: 20181562
• Report Number: 2124215-2024-56319
• Device Sequence Number: 8261424
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: 00878953000749
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 09/10/2024

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: 02/23/2022
• Device Model Number: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 0165536004
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/10/2024
• Date Device Manufactured: 02/23/2017
• 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: LOT 0164922014 UPN 72400024; PUMP: LOT 170299020 UPN 72400098
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male