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

Model Number	72400167
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product component: model number/catalog number: 72400024 and 72400098, batch/lot number: 728852012 and 714614003, model/catalog description: balloon fgs 61-70cm and control pump fgs.
Event or Problem Description
It was reported that the patient experienced mechanical dysfunction with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was explanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
Additional Manufacturer Narrative
Device analysis: analysis of the belt cuff fgs 7.5 cm confirmed a leak in the shell-adaptor junction with wear at the corner fold from the outside in.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.Additional product component: model number/catalog number: 72400024 and 72400098, serial number: null and null, batch/lot number: 728852012 and 714614003, model/catalog description: balloon fgs 61-70cm and control pump fgs.
Event or Problem Description
It was reported that the patient experienced mechanical dysfunction with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was explanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

• 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: 8537832
• Report Number: 2183959-2019-62415
• Device Sequence Number: 2431002
• Product Code: EZY
• UDI-Device Identifier: 00878953000787
• UDI-Public: 00878953000787
• 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: 2011
• 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): 06/19/2019

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: 06/07/2015
• Device Model Number: 72400167
• Device Catalogue Number: 72400167
• Device Lot Number: 657139005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention