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

Model Number	72404138
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant an 8.0cm cuff was tried not used with an artificial urinary sphincter (aus).The aus cuff was not implanted and a new 7.0cm cuff was implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8175277
• Report Number: 2183959-2018-61783
• Device Sequence Number: 1437075
• Product Code: EZY
• UDI-Device Identifier: 00878953003160
• UDI-Public: 00878953003160
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/05/2019
• Device Model Number: 72404138
• Device Catalogue Number: 72404138
• Device Lot Number: 1000049761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1
• Patient Age: 75 YR