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

Model Number	72400023
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing incontinence with his artificial urinary sphincter (aus).The pressure regulating balloon (prb) was collapsed.The device remains implanted.No additional patient complications have been reported at this time.
Additional Manufacturer Narrative
There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Additional Manufacturer Narrative
There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.B2: outcomes attrib to adv event, b5: describe event or problem, d6b: explant date have been updated.
Event or Problem Description
It was reported that the patient is experiencing incontinence with his artificial urinary sphincter (aus).The pressure regulating balloon (prb) is collapsed.All components were removed and replaced.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The balloon was visually and microscopically examined, and leak tested.Visual testing revealed that there was a tear at the sphere-adapter junction.Based on the information available and analysis results, the tear identified in the balloon could have caused or contributed to the reported clinical observation of mechanical anomalies.Also, the reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the balloon of this artificial urinary sphincter was collapsed and the patient was experiencing incontinence.All components were removed and replaced.There were no additional patient complications reported.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 15971737
• Report Number: 2124215-2022-52433
• Device Sequence Number: 17697294
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: 00878953000619
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 02/09/2023

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 Expiration Date: 08/30/2022
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Device Lot Number: 0185660006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/25/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/03/2023; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2017
• 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: UPN: 720133-01 LOT: 1000284516 CUFF; UPN: 720133-01 LOT: 1000284516 CUFF; UPN: 720133-01 LOT: 1000284516 CUFF; UPN: 72400098 LOT: 1000130561 PUMP; UPN: 72400098 LOT: 1000130561 PUMP; UPN: 72400098 LOT: 1000130561 PUMP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 24 YR
• Patient Sex: Male