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)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced recurring incontinence as the device stopped working.Upon explant, it was noted that the system did not have any fluid; however, the source of the fluid loss could not be identified.All components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected and microscopically examined.No damage or abnormalities were noted, no leaks were identified in the cuff.The balloon was visually inspected, microscopically examined, and tested for leaks.Visual inspection revealed that there was a tear in the shell caused by a sharp instrument consistent with explant damage; therefore, it is considered a secondary failure and not a product malfunction.The balloon was not functionally tested due to the identified damage.The pump was visually inspected, microscopically examined, and tested for leaks.No damage or abnormalities were noted, no leaks were identified in the component.The pump was not functionally tested because of the tear noted in the balloon.Based on the information available and analysis results, the reported clinical observation of the device stopped working and a fluid loss could not be confirmed.The reported patient symptom of urinary incontinence is a known risk associated with implant of these device as indicated in the instructions for use (ifu); consequently, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced recurring incontinence as the device stopped working.Upon explant, it was noted that the system did not have any fluid; however, the source of the fluid loss could not be identified.All components were removed and replaced.There were no 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17500148
• Report Number: 2124215-2023-42546
• Device Sequence Number: 6796892
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: 00878953000749
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 11/18/2024
• Device Model Number: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 1000360726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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: 1000448143; BALLOON: UPN: 72400024 / LOT: 1000448143; PUMP: UPN: 72404127 / LOT: 1000539363; PUMP: UPN: 72404127 / LOT: 1000539363
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown