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

Model Number	72400163
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) stopped working, believed to be due to fluid loss.It was noted that the patient frequently bikes, which could contribute to the device issue.Troubleshooting was attempted to no avail; therefore, a surgical procedure to remove the aus was performed.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The cuff was visually inspected and tested for leaks.Fluid loss due to a tear was noted along the lateral edge of the cuff shell, consistent with sharp instrument damage.The pump was visually inspected, leak and functionally tested.No damage or abnormalities were noted upon visual evaluation, and no leaks were identified.However, the pump did not pass functional examination.Based on the information available and analysis results, the pump not passing functional testing could have caused or contributed to the reported clinical observation of device not working properly.
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) stopped working, believed to be due to fluid loss.In addition, it was noted that the patient frequently bikes, which could contribute to the device issue.Troubleshooting was attempted to no avail; therefore, a surgical procedure to remove the aus was performed.There were no patient complications.

• 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: 20785180
• Report Number: 2124215-2024-74458
• Device Sequence Number: 9096944
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: 00878953000749
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 12/30/2024

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 Expiration Date: 04/15/2026
• Device Model Number: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 1000557278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN: 72400024 / LOT: 1100032095; BALLOON: UPN: 72400024 / LOT: 1100032095; PUMP: UPN: 72400098 / LOT: 1100039588; PUMP: UPN: 72400098 / LOT: 1100039588
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown