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

Model Number	72400164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported issue of atrophy and urinary 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.Investigation conclusion: based on all information received for this investigation, the conclusion code of no problem detected has been chosen.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter cuff component removed due to urethral atrophy resulting in recurring incontinence.A new artificial urinary sphincter cuff was implanted.Following the surgery, the patient was stable and the event resolved.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter cuff component removed due to urethral atrophy resulting in recurring incontinence.A new artificial urinary sphincter cuff was implanted.Following the surgery, the patient was stable and the event resolved.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported atrophy and urinary incontinence could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported allegation of a atrophy and urinary incontinence cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of known inherent risk was chosen as atrophy and urinary incontinence are documented as adverse events in the device labeling.

• 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
• MDR Report Key: 11946598
• Report Number: 2124215-2021-15783
• Device Sequence Number: 1085843
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: 00878953000756
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/08/2023
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 1000104057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR