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

Model Number	72400168
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced urinary incontinence that started in (b)(6) 2019 due to a cuff perforation with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was implanted.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
The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Event or Problem Description
It was reported that the patient experienced urinary incontinence that started in (b)(6) 2019 due to a cuff perforation with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was implanted.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: 8546932
• Report Number: 2183959-2019-62529
• Device Sequence Number: 10856080
• 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: 2018
• 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): 06/11/2019

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: 05/02/2021
• Device Model Number: 72400168
• Device Catalogue Number: 72400168
• Device Lot Number: 0133170004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention