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

Model Number 72400098

Device Problems Inflation Problem (1310); Mechanical Problem (1384)

Patient Problem Urinary Incontinence (4572)

Event Date 03/04/2022

Event Type  Injury  

Event Description

It was reported that the system would not activate or make the cuff work properly after 3 months of implant.The patient presented with incontinence urinary, the cuff would not fill to close around the urethra.No further patient complications were 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: 13903375
• MDR Text Key: 287909269
• Report Number: 2124215-2022-08508
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: 00878953000688
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/25/2022

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: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1000520251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONTROL PUMP FGS 72400098/1000520251; PRESS REG BALLOON 72400024 LOT 1000547383
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male