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

Model Number	72400168
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical implantation of an artificial urinary sphincter (aus), fluid droplets resembling condensation were observed inside the cuff immediately upon opening the packaging.Additional cuffs were subsequently opened and inspected, and similar findings were observed.As a result, the intended implantation could not be completed.The intervention was aborted, a temporary alternative procedure was performed, and the patient's aus implantation was rescheduled for a later date.No additional patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical 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 are linked to the device but unable to trace more specifically.
Event or Problem Description
It was reported that during the surgical implantation of an artificial urinary sphincter (aus), fluid droplets resembling condensation were observed inside the cuff immediately upon opening the packaging.Additional cuffs were subsequently opened and inspected, and similar findings were observed.As a result, the intended implantation could not be completed.The intervention was aborted, a temporary alternative procedure was performed, and the patient's aus implantation was rescheduled for a later date.No additional patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Media inspection was performed, during which droplets were observed.Subsequent spectroscopic analysis (ftir) identified the beaded liquid present inside the cuffs as fluorosilicone.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of "cosmetic/ appearance problem" was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the available information and analytical results, the beaded liquid found within the cuffs is consistent with the fluorosilicone lubricant oil used during the manufacturing process.The presence of this fluorosilicone may have caused or contributed to the reported clinical observation of a cosmetic/appearance issue.A conclusion code of cause traced to training was assigned to this investigation, due to insufficient training regarding the expected presentation of the ams 800 cuff following manufacturing, particularly with respect to the appearance of fluorosilicone beading.

• Brand Name: AMS 800 ARTIFICIAL URINARY SPHINCTER
• 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: 24620930
• Report Number: 2124215-2026-14742
• Device Sequence Number: 16008690
• Product Code: EZY
• UDI-Device Identifier: 00878953000794
• UDI-Public: (01)00878953000794(17)270808(10)1100171018
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72400168
• Device Catalogue Number: 72400168
• Device Lot Number: 1100171018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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
• Patient Sex: Unknown