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

Model Number	72400166
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Incontinence (1928); Unspecified Infection (1930); Inflammation (1932)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a replacement of an artificial urinary sphincter(aus) due to a malfunctioning cuff.An x-ray showed an empty cuff in both open and closed positions.When the cuff was explanted, it was found to be perforated.The patient was experiencing cystitis and urine leakage when standing and coughing.
Additional Manufacturer Narrative
H6 patient codes updated.
Event or Problem Description
It was reported that the patient experienced a replacement of an artificial urinary sphincter(aus) due to a malfunctioning cuff.An x-ray showed an empty cuff in both open and closed positions.When the cuff was explanted, it was perforated and had holes.The patient was experiencing cystitis and urine leakage when standing and coughing.
Event or Problem Description
It was reported that the patient experienced a replacement of an artificial urinary sphincter(aus) due to a malfunctioning cuff.An x-ray showed an empty cuff in both open and closed positions.When the cuff was explanted, it was perforated and had holes.The patient was experiencing cystitis and urine leakage when standing and coughing.
Additional Manufacturer Narrative
The cuff component was visually inspected, microscopically examined, and tested for leaks.A cuff leak was identified in the cuff shell.The cuff leak is consistent with wear and material fatigue at a fold.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Product analysis identified a product malfunction and confirmed the reported hole-perforation which caused fluid loss from the cuff component.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.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.

• 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: 10705876
• Report Number: 2183959-2020-04850
• Device Sequence Number: 3732471
• Product Code: EZY
• UDI-Device Identifier: 00878953000770
• UDI-Public: 00878953000770
• 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: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2021

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: 06/03/2020
• Device Model Number: 72400166
• Device Catalogue Number: 72400166
• Device Lot Number: 936023007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 01/20/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/16/2020; 01/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other