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

Model Number UNK-P-AUS

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)

Patient Problem Urinary Incontinence (4572)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that, following two to three months of satisfactory performance post-implant, the patient with this artificial urinary sphincter (aus) experienced recurring incontinence due to loss of function of the device.The patient underwent surgery to remove an replace the aus.At explant, air was observed inside the aus system but no holes were noticed upon removal.There were no patient complications reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this artificial urinary sphincter underwent a thorough analysis.The cuff was visually and microscopically examined, and leak tested.A tear consistent with a sharp instrument was identified, avulsion was present.The balloon was visually and microscopically examined, and leak tested.No anomalies were found with the balloon.The pump was visually and microscopically examined, and leak tested.No anomalies were found with the pump.Based on the information available and analysis results, the identified leak in the cuff could have caused or contributed to the reported clinical observation of mechanical issue and air in system.

Event Description

It was reported that, following two to three months of satisfactory performance post-implant, the patient with this artificial urinary sphincter (aus) experienced recurring incontinence due to loss of function of the device.The patient underwent surgery to remove an replace the aus.At explant, air was observed inside the aus system but no holes were noticed upon removal.There were no patient complications reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Type of Device: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14006734
• MDR Text Key: 288600040
• Report Number: 2124215-2022-09569
• Device Sequence Number: 1
• Product Code: EZY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-AUS
• Device Catalogue Number: UNK-P-AUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization