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

Model Number	72400168
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced recurring incontinence with the ams 800 artificial urinary sphincter.Urethroscopy assessment showed absence of erosion, but the cuff head appeared to be too large.It was decided to remove and replace the control pump and cuff.The explanted cuff two holes which could explain the leakage.
Additional Manufacturer Narrative
Returned product consisted of an ams800 occlusive cuff, pressure regulating balloon, and control pump.The ams800 occlusive cuff was visually and microscopically inspected and functionally tested.There was a perforation in the cuff shell at the fillet junction causing fluid loss.Inspection of the remainder of the device presented no other damage or irregularities.The fluid leak, and hole/perforation were both confirmed.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 (b)(6) found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Product analysis confirmed a perforation in the occlusive cuff based on visual and functional testing.The cuff damage is consistent with damage that can occur due to interaction with a sharp instrument.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.This complaint investigation conclusion code is for the adverse event occurred during the procedure and the device had no influence on event.Based on the results of this investigation, no escalation is necessary.
Event or Problem Description
It was reported that the patient experienced recurring incontinence with the ams 800 artificial urinary sphincter.Urethroscopy assessment showed absence of erosion, but the cuff head appeared to be too large.It was decided to remove and replace the control pump and cuff.The explanted cuff two holes which could explain the leakage.

• 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: 8885037
• Report Number: 2183959-2019-65627
• Device Sequence Number: 19512040
• Product Code: EZY
• UDI-Device Identifier: 00878953000794
• UDI-Public: 00878953000794
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 01/04/2021
• Device Model Number: 72400168
• Device Catalogue Number: 72400168
• Device Lot Number: 0114659008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention