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

Model Number	72400163
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Inflammation (1932); Urinary Retention (2119); Urinary Tract Infection (2120)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the implant procedure of this artificial urinary sphincter (aus), the patient experienced several episodes of urine retention, make it necessary to deactivate the pump and perform a delayed bladder catheterization.The patient developed a urinary tract infection requiring hospitalization for intravenous antibiotic therapy, requiring a safety cystostomy until the condition improve.The patient also developed hyperemia and phlogosis in the inguinal region, associated with fever.A surgical procedure was performed in which all components were removed.There were no further patient complications reported.
Event or Problem Description
It was reported that, after the implant procedure of this artificial urinary sphincter (aus), the patient experienced several episodes of urine retention, make it necessary to deactivate the pump and perform a delayed bladder catheterization.The patient developed a urinary tract infection requiring hospitalization for intravenous antibiotic therapy, requiring a safety cystostomy until the condition improve.The patient also developed hyperemia and phlogosis in the inguinal region, associated with fever.A surgical procedure was performed in which all components were removed.There were no further patient complications reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, the investigation conclusion code of known inherent risk of device was chosen as the allegation relates to fever, infection, inflammation, urinary retention, redness which are addressed in our labeling and risk documentation.
Event or Problem Description
It was reported that, after the implant procedure of this artificial urinary sphincter (aus), the patient experienced several episodes of urinary retention, making it necessary to deactivate the pump and perform a delayed bladder catheterization.The patient developed a urinary tract infection requiring hospitalization for intravenous antibiotic therapy, requiring a safety cystostomy until the condition improved.The patient also developed hyperemia and phlogosis in the inguinal region, associated with fever.A surgical procedure was performed in which all components were removed.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected, and leak tested.The cuff passed the visual inspection.No damage or abnormalities were found.The cuff passed the leakage test.The balloon was visually inspected, leak and functionally tested.Visual examination revealed that the balloon was identified to have folds.The balloon passed the leakage test.The balloon failed functional testing with an output pressure reading above the specification.The pump was visually inspected, leak and functionally tested.Visual examination revealed that the pump had bodily fluid in the block chamber.The pump passed the leakage test.To avoid damaging the test equipment, the control pump was not functionally tested.Based on the information available and analysis results, the reported patient symptoms of fever, urinary tract infection, inflammation, urinary retention and redness are known risks associated with ams 800 procedures and are noted as such in the device instructions for use; therefore, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 20365255
• Report Number: 2124215-2024-61801
• Device Sequence Number: 3889713
• Product Code: EZY
• UDI-Device Identifier: 00878953000749
• UDI-Public: (01)00878953000749(17)270307(10)1100098864
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000053
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 72400163
• Device Catalogue Number: 72400163
• Device Lot Number: 1100098864
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 03/17/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/29/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN: 72400024 / LOT: 1100455810; BALLOON: UPN: 72400024 / LOT: 1100455810; BALLOON: UPN: 72400024 / LOT: 1100455810; PUMP: UPN: 72400098 / LOT: 1100447760; PUMP: UPN: 72400098 / LOT: 1100447760; PUMP: UPN: 72400098 / LOT: 1100447760
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male