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

Model Number	72400160
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for balloon is (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.Hole/perforated and mechanical issue are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that a crack was found in the cuff connecting tube.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for balloon is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.The balloon and tubing were contaminated with bodily tissue.The balloon passed the leakage test and did not pass functional testing, with an output pressure reading of 71.2 cm h2o, which is above specification (balloon pressure specification: 61 to 70 cm h2o).The cuff tab was cut from a sharp instrument.The cuff passed the leakage test.The tubing was worn due to overstretching/twisting and passed the leakage test.The pump had contamination (bodily fluid) obstructing the pump tubing and pump block.The pump was unable to perform leakage testing due to contamination obstruction in the pump tubing and pump block, and to avoid damaging the test equipment, the control pump was not functionally tested.Based on the information available and analysis results, the risk review and labeling review identified that the adverse events of mechanical issue and hole/perforate are known risks of the device.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.The allegations of mechanical issue and hole/perforate were unable to be confirmed.However, the balloon not passing the functional test could affect product performance; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that a crack was found in the cuff connecting tube.The device was explanted and replaced.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: 23873687
• Report Number: 2124215-2025-88106
• Device Sequence Number: 5331091
• Product Code: EZY
• UDI-Device Identifier: 00878953000718
• UDI-Public: (01)00878953000718(17)300622(10)1100747738
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72400160
• Device Catalogue Number: 72400160
• Device Lot Number: 1100747738
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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 LOT 1100688433, UPN 72400024; BALLOON LOT 1100688433, UPN 72400024; PUMP LOT 1100692779, UPN 72400098; PUMP LOT 1100692779, UPN 72400098
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male