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

Model Number	72400165
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported performance allegation cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) revision surgery due to the device not working.There were no patient complications.
Event or Problem Description
It was reported that the patient underwent an artificial urinary sphincter (aus) revision surgery due to the device not working.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 800 underwent a thorough analysis.The cuff was visually inspected, and leak tested, no visual damages and abnormalities were identified, and the leak test was passed.Visual inspection of the pump did not identify any anomalies and the component passed leak testing.The balloon was visually inspected identifying a damage in the shell proximal to the sphere-adapter junction consistent with a sharp instrument; therefore, the component did not pass leak testing.Based on the information available and analysis results, the hole in the shell could have caused or contributed to the reported clinical observation of the device not working.A conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• 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: 17717369
• Report Number: 2124215-2023-48973
• Device Sequence Number: 20637988
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: 00878953000763
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 1100102305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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: 72400024/1100258375; BALLOON: 72400024/1100258375; PUMP: 72404127/1100273199; PUMP: 72404127/1100273199
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown