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

Model Number	72400167
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 with this artificial urinary sphincter (aus) was experiencing reappearance of urinary incontinence.An x-ray confirmed that the system was drained and there was a hole in the cuff.A replacement surgery was performed in which all components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually and microscopically examined.A cuff pinhole was identified proximal to the edge/seam consistent with wear at a corner of a fold.The balloon and pump were visually and microscopically tested.No anomalies were found with the components.Based on the information available and analysis results, the hole identified in the cuff could have caused or contributed to the reported clinical observation of fluid leak and material hole.The reported patient symptom is a known risk associated with implant of these devices as indicated in the instructions for use.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) was experiencing reappearance of urinary incontinence.An x-ray confirmed that the system was drained and there was a hole in the cuff.A replacement surgery was performed in which 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: 16368619
• Report Number: 2124215-2023-05776
• Device Sequence Number: 12648222
• 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: 2012
• 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): 05/11/2023

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: 01/24/2016
• Device Model Number: 72400167
• Device Catalogue Number: 72400167
• Device Lot Number: 692230004
• 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: 04/20/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2011
• 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 756338002; BALLOON: UPN 72400024/ LOT 756338002; PUMP: UPN 72400098/ LOT 7710090; PUMP: UPN 72400098/ LOT 7710090
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown