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

Model Number	72400170
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a removal of an artificial urinary sphincter(aus) device due to a hole in the cuff and the device not functioning.A patient outcome was not reported.
Event or Problem Description
It was reported that the patient experienced a removal of an artificial urinary sphincter(aus) device due to a hole in the cuff and the device not functioning.A patient outcome was not reported.
Additional Manufacturer Narrative
A pinhole was identified in the occlusive cuff shell.The damage is consistent with wear at a fold.The product record review indicated that the reported events do not represent an unanticipated event.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.The balloon component was visually inspected, microscopically examined, and tested for leaks.No damage or abnormality was noted, no leaks were identified in the balloon.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation.Based on the results of this investigation, no escalation is required.

• 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: 10211910
• Report Number: 2183959-2020-02731
• Device Sequence Number: 13980079
• Product Code: EZY
• UDI-Device Identifier: 00878953000800
• UDI-Public: 00878953000800
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 01/21/2018
• Device Model Number: 72400170
• Device Catalogue Number: 72400170
• Device Lot Number: 0810103002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other