MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	72404127
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404130.Serial number: n/a.Batch/lot number: 1100207049.Model/catalog description: belt cuff fgs 4.0 cm iz unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100207345.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that a patient was dissatisfied with his artificial urinary sphincter (aus).The balloon and pump were found to be malpositioned.As a result, the entire device was removed and replaced, with the new device implanted in the appropriate anatomical position.No patient complications were reported.
Event or Problem Description
It was reported that a patient was dissatisfied with his artificial urinary sphincter (aus).The balloon and pump were found to be malpositioned.As a result, the entire device was removed and replaced, with the new device implanted in the appropriate anatomical position.No patient complications were reported.
Event or Problem Description
It was reported that a patient was dissatisfied with his artificial urinary sphincter (aus).The balloon and pump were found to be malpositioned.As a result, the entire device was removed and replaced, with the new device implanted in the appropriate anatomical position.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404130.Serial number: n/a.Batch/lot number: 1100207049.Model/catalog description: belt cuff fgs 4.0 cm iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100207345.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).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.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 malposition, pump 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 information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
Model number/catalog number: 72404130.Serial number: n/a.Batch/lot number: 1100207049.Model/catalog description: belt cuff fgs 4.0 cm iz.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72400024.Serial number: n/a.Batch/lot number: 1100207345.Model/catalog description: balloon fgs 61-70 cm.Unique identifier (udi) #: (b)(4).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.The device history record (dhr) review was unable to be performed.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 malposition, pump 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 information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established 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: 25883944
• Report Number: 2124215-2026-38966
• Device Sequence Number: 21324003
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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 Expiration Date: 04/10/2024
• Device Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100116842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: Not provided; 08/21/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/24/2026; 09/14/2026
• Date Device Manufactured: 04/11/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male