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

Model Number 72404133

Device Problems Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Urinary Incontinence (4572)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient had persistent urine leakage with an artificial urinary sphincter (aus).The physician decided to perform an intervention to replace the cuff for a smaller component.It was indicated that the patient was obese and due to the pressure exerted by the anatomy, the cuff could not close properly.The patient fully recovered following the intervention.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient had persistent urine leakage with an artificial urinary sphincter (aus).The physician decided to perform an intervention to replace the cuff for a smaller component.It was indicated that the patient was obese and due to the pressure exerted by the anatomy, the cuff could not close properly.The patient fully recovered following the intervention.

• 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: 12956841
• MDR Text Key: 281886533
• Report Number: 2124215-2021-37602
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953003115
• UDI-Public: 00878953003115
• Combination Product (y/n): Y
• Reporter Country Code: CI
• PMA/PMN Number: P000053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2020
• Device Model Number: 72404133
• Device Catalogue Number: 72404133
• Device Lot Number: 1000371007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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
• Patient Age: 62 YR
• Patient Sex: Male