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

Model Number	72400165
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient ams 800 artificial urinary sphincter consisting of cuff, balloon, and pump was replaced because the device was defective.
Additional Manufacturer Narrative
Correction on d6, additional information on d7.
Event or Problem Description
It was reported that the patient ams 800 artificial urinary sphincter consisting of cuff, balloon, and pump was replaced because the device was defective.
Additional Manufacturer Narrative
Product analysis confirmed a device malfunction.Analysis showed a leak in the occlusive cuff shell.The damage is consistent with fatigue and wear.The investigation conclusion code of cause traced to component failure was chosen because complaint allegations were confirmed through product analysis due to the device condition.This complaint investigation conclusion code is utilized for a component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.This conclusion is supported by the following objective evidence: an allegation that the device was not working as expected was reported.The ams 800 device was visually and microscopically examined.Product analysis identified a fluid leak in the occlusive cuff shell.The fluid leak was attributed to wear and fatigue at the corner of a fold.Device analysis confirmed a malfunction.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing record found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Potential emerging trends are captured as part of the post market signal evaluation and escalation process.A risk review of the aus 800 occlusive cuff was completed using ams 800 hazard analysand confirmed therapeutic response, altered is included as a harm, although the appropriate hazardous situation could not be identified with the limited information provided.Based on this review, this complaint does not represent a new or unanticipated event.Review of the complaint information and the directions for use ifu did not reveal any evidence of device off-label use or failure to follow instructions; therefore, no updates to the document are required at this time.
Event or Problem Description
It was reported that the patient ams 800 artificial urinary sphincter consisting of cuff, balloon, and pump was replaced because the device was defective.

• 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: 9465447
• Report Number: 2183959-2019-68076
• Device Sequence Number: 14186462
• 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: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2020

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: 11/26/2022
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 1000013495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/23/2019; 02/27/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/06/2020; 03/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention