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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number: 72404127, lot number: 104357003, model description: control pump fgs iz.Model number: 72400023, lot number: 890536006, model description: balloon fgs 51-60 cm.
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) was explanted because the patient became incontinent again.A new aus device was implanted.There were no further complications.It was further reported there was fluid loss from the device.
Additional Manufacturer Narrative
Device evaluation: the complaint component was returned and analyzed, and the reported allegation of fluid loss was confirmed via product analysis.Based on the results of this investigation, no escalation is necessary.The ams800 occlusive cuff was visually inspected and functionally tested.There was a leak in the pillow due to wear at a fold from the outside in.The ams800 control pump was visually inspected.No leak was found.The pump was not functionally tested due to contamination.Device information: model number: 72404127, lot number: 104357003, model description: control pump fgs iz.Model number: 72400023, lot number: 890536006, model description: balloon fgs 51-60 cm.
Event or Problem Description
It was reported that the artificial urinary sphincter (aus) was explanted because the patient became incontinent again.A new aus device was implanted.There were no further complications.It was further reported there was fluid loss from the device.

• 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: 8496413
• Report Number: 2183959-2019-62085
• Device Sequence Number: 16560095
• Product Code: EZY
• UDI-Device Identifier: 00878953003139
• UDI-Public: 00878953003139
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 02/14/2016
• Device Model Number: 72404135
• Device Catalogue Number: 72404135
• Device Lot Number: 921518015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 06/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR