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

Model Number	72400098
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812); Erythema (1840); Swelling/ Edema (4577)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with a bulge in the lower abdomen, from which pus emerged.Additionally, the pump area was red and swollen; therefore, a removal surgery was scheduled.No additional information was provided.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with a bulge in the lower abdomen, from which pus emerged.Additionally, the pump area was red and swollen; therefore, a removal surgery was performed.No additional information was provided.
Additional Manufacturer Narrative
Additional information updated: b2: outcomes attrib to adv event.B5: describe event/problem.H6: impact codes.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The pump was visually inspected, leak and functionally evaluated, and it passed all testing.The cuff was visually inspected and tested for leaks.While the component passed visual inspection, it did not pass the leakage test due to fluid loss caused by a pinhole located along the lateral edge of the cuff shell, consistent with sharp instrument damage.The balloon was visually inspected and leak tested.No damage or abnormalities were noted, and no leaks were identified.The component was not functionally tested, as the lot number was not provided along with the balloon specifications.The reported patient symptoms of abscess, purulent discharge, swelling and redness are known risks associated with ams 800 procedures and are noted as such in the device instructions for use.
Additional Manufacturer Narrative
Additional information updated: b5: describe event/problem.D6b: explant date.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The pump was visually inspected, leak and functionally evaluated, and it passed all testing.The cuff was visually inspected and tested for leaks.While the component passed visual inspection, it did not pass the leakage test due to fluid loss caused by a pinhole located along the lateral edge of the cuff shell, consistent with sharp instrument damage.The balloon was visually inspected and leak tested.No damage or abnormalities were noted, and no leaks were identified.The component was not functionally tested, as the lot number was not provided along with the balloon specifications.The reported patient symptoms of abscess, purulent discharge, swelling and redness are known risks associated with ams 800 procedures and are noted as such in the device instructions for use.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with a bulge in the lower abdomen, from which pus emerged.Additionally, the pump area was red and swollen; therefore, a removal surgery was performed.No additional patient complications were reported.

• 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: 21949480
• Report Number: 2124215-2025-28087
• Device Sequence Number: 18406084
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 06/23/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72400098
• Device Catalogue Number: 72400098
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 06/04/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/30/2025; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Sex: Unknown