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

Model Number	72400168
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that after six weeks of the artificial urinary sphincter (aus) implantation, the cuff is unable to close the bladder neck, even though the device is functional.Therefore, the patient is experiencing recurring incontinence.A revision surgery was requested to remove the bladder cuff and place a new cuff on the bulbar urethra.The revision surgery has not been planned.

• 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 ; 4089353452
• MDR Report Key: 13551769
• Report Number: 2124215-2022-04986
• Device Sequence Number: 5051339
• Product Code: EZY
• UDI-Device Identifier: 00878953000794
• UDI-Public: 00878953000794
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: 04/19/2022
• Device Model Number: 72400168
• Device Catalogue Number: 72400168
• Device Lot Number: 0169821012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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: Other
• Patient Age: 26 YR
• Patient Sex: Male