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

Model Number	72400098
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2025
Type of Reportable Event	Serious Injury
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 there was a crack in the pump connecting tube, so the pump and a cuff were replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for cuff is (b)(4).Udi field (d4) concomitant product udi for balloon is (b)(4).
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 there was a crack in the pump connecting tube, so the pump and a cuff were replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for cuff 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.Visual inspection of the cuff identified folds, not passing visual inspection; however, the cuff passed the leakage test.Visual inspection of the pump revealed that the pump tubing was trimmed down at the adaptor junction and was not returned for analysis, not passing the test.Leakage testing of the pump was successfully passed.Functional testing did not pass and showed that the pump failed the poppet pressure test, with an output reading below specification.The pump pressure specification is 14.4- 22.5 psi.Additionally, the pump failed the low flow test, with an output reading below pressure, which is out of specification.The pump pressure specification is equal to or greater than 2.1 psi.Based on the information available and analysis results, the allegation of a mechanical issue was most likely determined to be the pump failing the poppet pressure test and the low flow test, with output readings below specification from the functional test performed.Additionally, the allegation of tube - hole/perforated was not confirmed due to the pump tubing being trimmed down at the adaptor junction and not returned for analysis.A conclusion code of cause traced to component failure 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: 22516383
• Report Number: 2124215-2025-47340
• Device Sequence Number: 18449417
• Product Code: EZY
• UDI-Device Identifier: 00878953000688
• UDI-Public: (01)00878953000688(17)250510(10)1000426831
• 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: 2021
• 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): 10/21/2025

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 Expiration Date: 05/10/2025
• Device Model Number: 72400098
• Device Catalogue Number: 72400098
• Device Lot Number: 1000426831
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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 1000425740, UPN 72400024.; BALLOON LOT 1000425740, UPN 72400024.; CUFF LOT 1000382629, UPN 72400160.; CUFF LOT 1000382629, UPN 72400160.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male