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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Urinary Incontinence (4572)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.
Event or Problem Description
It was reported that recurring incontinence has persisted despite of artificial urinary sphincter (aus) revisions.A revision surgery was performed to downsize the transcorporal cuff to a 6.0 cm cuff, although the device was functioning as expected.During surgery, a small perforation was made in the urethra, though proximal to the location of the cuff.The surgeon repaired the urethral defect and was willing to place the new cuff despite of the urethral defect; as he believes that another perineal incision could not be performed to this patient.The procedure was successfully completed.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11440356
• Report Number: 2183959-2021-00837
• Device Sequence Number: 17295996
• Product Code: EZY
• UDI-Device Identifier: 00878953003139
• UDI-Public: 00878953003139
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: 01/30/2021
• Device Model Number: 72404135
• Device Catalogue Number: 72404135
• Device Lot Number: 1000389786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR