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

Model Number 72404127

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930); Burning Sensation (2146)

Event Date 12/22/2021

Event Type  Injury  

Event Description

It was reported that the patient with this artificial urinary sphincter (aus) developed an infection.Per the physician, this was due to the implant procedure.The pump of the aus eroded in the scrotum and the cuff also eroded.The patient complained of a burning sensation for several months.The device was explanted to allow the patient to heal.Antibiotics were prescribed.No additional patient complications were reported.

Event Description

It was reported that the patient with this artificial urinary sphincter (aus) developed an infection.Per the physician, this was due to the implant procedure.The pump of the aus eroded in the scrotum and the cuff also eroded.The patient complained of a burning sensation for several months.The device was explanted to allow the patient to heal.Antibiotics were prescribed.No additional patient complications were reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the pressure regulating balloon, occlusive cuff, and control pump underwent a thorough analysis.The three components were visually and microscopically examined, and functionally tested.No anomalies were found with the cuff or pump.The balloon did not pass functional testing due to pressure higher than specification.Based on the information available and analysis results, it was not possible to confirm the most probable cause of the reported infection.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• 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: 13950526
• MDR Text Key: 288199147
• Report Number: 2124215-2022-08957
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: 00878953003078
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P000053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2023
• Device Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100010615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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
• Treatment: BALLOON: UPN 72400024/ LOT 1100011744; BALLOON: UPN 72400024/ LOT 1100011744; CUFF: UPN 72404130/ LOT 1100016499; CUFF: UPN 72404130/ LOT 1100016499
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White