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

Model Number	720133-01
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not working properly.Two weeks later a revision surgery was performed, upon examination a hole in the cuff was found.The balloon remained implanted, and the cuff and pump were explanted 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 inspected, and a pinhole was found in the cuff shell consistent with wear at a corner of a fold.The cuff did not pass the leak testing performed.The pump was visually inspected and underwent leak testing.No damages nor abnormalities were found.In addition, it did pass leak testing.Based on the information available and analysis results, the pinhole found in the cuff could have caused or contributed to the reported clinical observation of mechanical issue; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was not working properly.Two weeks later a revision surgery was performed, upon examination a hole in the cuff was found.The balloon remained implanted, and the cuff and pump were explanted 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18233815
• Report Number: 2124215-2023-66929
• Device Sequence Number: 3227633
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: 00878953005461
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/27/2024

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: 08/05/2021
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1000314051
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• 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: 1000546889; BALLOON: UPN: 72400024/ LOT: 1000546889; PUMP: UPN: 72400098 / LOT: 1000529967; PUMP: UPN: 72400098 / LOT: 1000529967
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male