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

Model Number 72404131

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

Patient Problems Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 02/11/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to revise this artificial urinary sphincter (aus) due to an infection surrounding the device, lower abdomen pain, fever, and urinary tract infection (uti) symptoms.The patient was prescribed antibiotics and had antibiotic iv during the 7 day hospitalization stay and was discharged on (b)(6) 2021.The aus cuff, pump, and balloon was explanted.The patient is expected to fully recover.

Event Description

It was reported that the patient underwent a surgical procedure to explant the artificial urinary sphincter (aus) due to an infection surrounding the device.The patient was also experiencing lower abdomen pain, fever, and urinary tract infection (uti) symptoms.The patient was prescribed antibiotics and had antibiotic iv during the 7 day hospitalization stay and was discharged on (b)(6) 2021.The patient is expected to fully recover.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the pinhole tear identified during analysis is unlikely the cause of the reported allegations, therefore, the patient symptoms of infection surrounding the device, pain, fever, and urinary tract infection was unable to be confirmed.Note that the pinhole identified during analysis is consistent with sharp instrument damage during the explant procedure.The patient symptoms of infection pain/discomfort are known risk associated with this type of procedure and noted as such in the instructions for use (ifu).Technical analysis: the product was returned for analysis to our post market quality assurance laboratory.Visual examination identified a pinhole tear in the cuff shell, which is consistent with sharp instrument damage during the explant procedure.Functional testing on the cuff identified a fluid leak at the pinhole tear in the cuff shell.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Infection and pain/discomfort are known potential risk associated with the implant procedure and are noted as such in the ifu.Device history record: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Type of Device: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11772757
• MDR Text Key: 248997566
• Report Number: 2124215-2021-12313
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953003092
• UDI-Public: 00878953003092
• Combination Product (y/n): Y
• PMA/PMN Number: P000053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2016
• Device Model Number: 72404131
• Device Catalogue Number: 72404131
• Device Lot Number: 115834006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Date Manufacturer Received: 05/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention