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

Model Number 72400024

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504)

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

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that this artificial urinary sphincter (aus) was not working properly.A revision surgery was performed, upon examination fluid leakage due to a puncture near the hub of the balloon was found.The device was explanted.No patient complications were reported.

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 this artificial urinary sphincter (aus) was not working properly.A revision surgery was performed, upon examination fluid leakage due to a puncture near the hub of the balloon was found.The device was explanted and replaced.No patient complications were reported.

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.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The balloon was visually inspected and underwent leak testing.A large tear was found in the balloon shell at the sphere -adapter junction consistent with material fatigue.Based on the information available and analysis results, the tear found in the balloon could have caused or contributed to the reported clinical observation of mechanical issue; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that this artificial urinary sphincter (aus) was not working properly.A revision surgery was performed, upon examination fluid leakage due to a puncture near the hub of the balloon was found.The device was explanted and replaced.No 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18553467
• MDR Text Key: 333374509
• Report Number: 2124215-2024-02975
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953000626
• UDI-Public: 00878953000626
• 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: 03/22/2024

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: 72400024
• Device Catalogue Number: 72400024
• Device Lot Number: 1100285782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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: CUFF: UPN: 72404131 / LOT: 1100271363; CUFF: UPN: 72404131 / LOT: 1100271363; PUMP: UPN: 72404127 / LOT: 1100257015; PUMP: UPN: 72404127 / LOT: 1100257015
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR