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

Model Number 72400161

Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504)

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

Event Date 12/14/2023

Event Type  Injury  

Event Description

It was reported that the patient visited the hospital because the artificial urinary sphincter was not performing properly.The patient underwent surgery two weeks later and inspection revealed a crack in the cuff connecting tube.All components were removed and replaced.There were no patient complications.

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, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that the patient visited the hospital because the artificial urinary sphincter was not performing properly.The patient underwent surgery two weeks later and inspection revealed a crack in the cuff connecting tube.All components were removed and replaced.There were no patient complications.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this artificial urinary sphincter underwent a thorough analysis.The cuff was visually and microscopically examined, and leak tested.A pinhole tear was identified if the cuff shell consistent with wear at a fold, therefore the cuff did not pass the leak test.The balloon and pump were visually and microscopically examined, and leak tested.No anomalies were found with these components.Based on the information available and analysis results, the leak identified in the cuff confirmed the reported event of device not performing as expected.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 18534538
• MDR Text Key: 333123261
• Report Number: 2124215-2023-76071
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953000725
• UDI-Public: 00878953000725
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/10/2024

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: 72400161
• Device Catalogue Number: 72400161
• Device Lot Number: 1000323529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• 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
• Treatment: BALLOONUPN: 72400024LOT: 1000295124; BALLOONUPN: 72400024LOT: 1000295124; PUMPUPN: 72400098LOT: 1000426517; PUMPUPN: 72400098LOT: 1000426517
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male