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

Model Number	72404135
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	07/21/2021
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.Neither the reported patient symptoms or device performance allegation can 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 a surgical procedure to revise this artificial urinary sphincter (aus) due to recurring incontinence requiring the patient to use 3 pads per day and atrophy as a result of the cuff being too large for the patient.The aus 6.5cm cuff was explanted and downsized to an aus 5.5cm cuff with no clinical consequences to the patient.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12310163
• Report Number: 2124215-2021-24278
• Device Sequence Number: 4252375
• Product Code: EZY
• UDI-Device Identifier: 00878953003139
• UDI-Public: 00878953003139
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 02/24/2021
• Device Model Number: 72404135
• Device Catalogue Number: 72404135
• Device Lot Number: 1000402476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR