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

Model Number	72400023
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported balloon tear cannot be established as the product is not available for analysis.Device history record (dhr) : the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis : the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient had a surgical procedure to revise an artificial urinary sphincter(aus) due to recurring incontinence two and a half years after the aus was implanted.When the aus was explanted, a hole was found in the prb.A new pump and prb was implanted and the device was tested and fully functioning after verification by cystoscope.No further patient complications were reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 12180962
• Report Number: 2124215-2021-19788
• Device Sequence Number: 909679
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 05/30/2023
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Device Lot Number: 1000114184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/16/2021
• 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: 67 YR