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

Model Number	72400165
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient ams 800 artificial urinary sphincter (aus) started to malfunction in 2018.The entire aus system was removed and replaced with a new one.No further issues were reported in relation to this event.
Additional Manufacturer Narrative
Returned product consisted of an ams800 occlusive cuff and regulating balloon.The ams800 cuff was visually, microscopically, and functionally tested.No leak was determined.Inspection of the remainder of the device revealed no other damage or irregularities.The ams800 balloon was visually and microscopically tested.Microscopic examination of the device revealed that there is a balloon hole causing a leak in the shell.Fluid loss was confirmed because of the tear.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for a hole and a leak due to fatigue and avulsion a labeling review is not required for this complaint as there is no indication of device misuse, off-label, or failure to follow instructions.A risk review is not required as the complaint was determined not to be associated with training, a new product, or a new hazardous situation.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.There may be multiple ways for this damage to occur including longevity of the implant which would result in end of life of the component.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.
Event or Problem Description
It was reported that the patient ams 800 artificial urinary sphincter (aus) started to malfunction in 2018.The entire aus system was removed and replaced with a new one.No further issues were reported in relation to this event.

• 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: 8791830
• Report Number: 2183959-2019-65036
• Device Sequence Number: 13937434
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: 00878953000763
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 10/28/2010
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 433018006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention