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

Model Number	UNK-P-AUS
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) revision surgery because he was unable to pump due to fluid loss.The location and source of the fluid loss was the balloon.Upon explant, a hole in the tubing was identified, it is suspected that the physician may have accidentally cut it.The hole was identified because saline was inserted into the balloon, and it did not holt the fluid.There is not much fluid left in the device.The entire system was removed and replaced with a new one.No patient complications were reported.
Additional Manufacturer Narrative
Correction to fields d1: brand name, d2b: pro code (product code), d4: model number, catalog number, expiration date and unique identifier (udi) #.
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) revision surgery because he was unable to pump due to fluid loss.The location and source of the fluid loss was the balloon.Upon explant, a hole in the tubing was identified, it is suspected that the physician may have accidentally cut it.The hole was identified because saline was inserted into the balloon, and it did not hold the fluid.There was not much fluid left in the device.The entire system was removed and replaced with a new one.No patient complications were reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: 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: 20829011
• Report Number: 2124215-2024-74845
• Device Sequence Number: 18325308
• Product Code: EZY
• UDI-Device Identifier: 00878953000664
• UDI-Public: 00878953000664
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: UNK-P-AUS
• Device Catalogue Number: UNK-P-AUS
• Device Lot Number: 1100262202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/24/2024
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Unknown