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

Model Number 72404131

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that the patient underwent a surgical procedure to explant this artificial urinary sphincter (aus) due to cuff inflation issues.All components of the existing aus were explanted and replaced with a new aus.No patient complications were reported.

• 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
• MDR Report Key: 15003364
• MDR Text Key: 295808976
• Report Number: 2124215-2022-25313
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953003092
• UDI-Public: 00878953003092
• 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
• Report Date: 07/13/2022

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: Health Professional
• Device Expiration Date: 02/05/2018
• Device Model Number: 72404131
• Device Catalogue Number: 72404131
• Device Lot Number: 0162904009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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: 72400024/182482008; PUMP: 72404127/172082017
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male