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

Model Number	72400165
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporter stated that the device was implanted in 2011 and the specific implant date was not available, therefore, the date (b)(6) 2011 was used as estimate.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 underwent an artificial urinary sphincter (aus) replacement surgery due to recent urinary incontinence.During the procedure, it was noticed that the system was drained which led to a mechanical failure.All components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
The reporter stated that the device was implanted in 2011 and the specific implant date was not available, therefore, the date (b)(6) 2011 was used as estimate.Upon receipt of this artificial urinary sphincter (aus) at our quality assurance laboratory, the returned components underwent a thorough analysis.The cuff and pump were visually examined and microscopically tested.No anomalies were found with both components and performed within specifications.The reservoir was visually examined and functionally tested.Scaling on the balloon shell was observed and two pinhole tears were identified during the leak test within the scaling.Based on the information available and analysis results, the tear identified in the balloon could have caused or contributed to the reported clinical observation of fluid leak.
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) replacement surgery due to recent urinary incontinence.During the procedure, it was noticed that the system was drained which led to a mechanical failure.All components were removed and replaced.No patient complications were 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: 16368884
• Report Number: 2124215-2023-05722
• Device Sequence Number: 7544210
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: 00878953000763
• 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: 2011
• 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): 05/08/2023

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: 01/12/2012
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 479526002
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 698181017; BALLOON: UPN 72400024 / LOT 698181017; PUMP: UPN 72400098 / LOT 690851014; PUMP: UPN 72400098 / LOT 690851014
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female