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

Model Number	72400166
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis and there was no report of a device performance allegation during treatment.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 experienced recurring incontinence with this artificial urinary sphincter (aus) since the device stopped working properly.A surgery was performed and the device was removed.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff, pump and balloon were visually and microscopically examined, and leak tested.No anomalies were found with the pump.Visual testing of the cuff revealed that there was a tear at the fold.Leak testing of the balloon revealed that there was a leak in the balloon shell.Based on the information available and analysis results, the tear found in the cuff and the leak found in the balloon identified could have caused or contributed to the reported clinical observation of mechanical non-conformance.B5 describe event or problem was updated.
Event or Problem Description
It was reported that the patient experienced recurring incontinence with this artificial urinary sphincter (aus) since the device stopped working properly.A surgery was performed and the device was removed and replaced.There were no additional patient complications reported.
Event or Problem Description
It was reported that the patient experienced recurring incontinence with this artificial urinary sphincter (aus) since the device stopped working properly.A surgery was performed and the device was removed.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff, pump and balloon were visually and microscopically examined, and leak tested.No anomalies were found with the pump.Visual testing of the cuff revealed that there was a tear at the fold.Leak testing of the balloon revealed that there was a leak in the balloon shell.Based on the information available and analysis results, the tear found in the cuff and the leak found in the balloon identified could have caused or contributed to the reported clinical observation of mechanical non-conformance.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15699904
• Report Number: 2124215-2022-44255
• Device Sequence Number: 8192974
• Product Code: EZY
• UDI-Device Identifier: 00878953000770
• UDI-Public: 00878953000770
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2023

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: 06/28/2016
• Device Model Number: 72400166
• Device Catalogue Number: 72400166
• Device Lot Number: 719352003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 02/07/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/06/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown