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

Model Number	72400023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 800 pressure regulated balloon underwent a thorough analysis.It was visually and microscopically inspected, and leak tested.The balloon passed the leak test.The balloon failed functional testing.Based on the information available and analysis results, the high-pressure malfunction identified in the balloon could have caused or contributed to the device being removed.The specific event date was not provided, therefore the date (b)(6) 2023 was used as estimate.
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) had the pressure regulated balloon returned without initial reporter and performance allegation information.Analysis of the returned device identified that the balloon failed functional testing.

• 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: 16645504
• Report Number: 2124215-2023-14487
• Device Sequence Number: 5340281
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: 00878953000619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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 Model Number: 72400023
• Device Catalogue Number: 72400023
• Device Lot Number: 1100134914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown