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

Model Number	72404137
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was scheduled to have the artificial urinary sphincter removed due to incontinences as a large bit of extra issue was left around the urethra at the time of cuff placement, in order to provide some protection to a previously damaged urethra.This does not appear to have been effective though, as urinary incontinence is still bothersome.A revision surgery to change the cuff size is booked for (b)(6) 2021.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported cuff was too small resulting in incontinence could not be established as the product is not available for analysis.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of the cuff was too small resulting in incontinence cannot be confirmed.Based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter (aus) removed due to incontinence as a large bit of extra issue was left around the urethra at the time of cuff placement, in order to provide some protection to a previously damaged urethra.This does not appear to have been effective though, as urinary incontinence was still bothersome.The patient had the aus cuff replaced with a smaller cuff.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11697236
• Report Number: 2124215-2021-09300
• Device Sequence Number: 11508329
• Product Code: EZY
• UDI-Device Identifier: 00878953003153
• UDI-Public: 00878953003153
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 01/22/2021
• Device Model Number: 72404137
• Device Catalogue Number: 72404137
• Device Lot Number: 1000384428
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 80 YR